ML20205L786
| ML20205L786 | |
| Person / Time | |
|---|---|
| Issue date: | 04/13/1999 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Munro J GAMMA-MED |
| Shared Package | |
| ML20205L788 | List: |
| References | |
| SSD, NUDOCS 9904140292 | |
| Download: ML20205L786 (4) | |
Text
1 April 13, 1999 l
Mr. John J. Munro,111 Chief Executive Officer GammaMed USA 2464 E. Stadium Blvd.
i Ann Arbor, MI 48104
Dear Mr. Munro:
This letter is in respones to your letter dated March 22,1999, withdrawing your application for reactivation of the Model GammaMed 12it brachytherapy HDR remote afterloader (Registration i
Certificate NR-555-D-804-S). In accordance with your request, we terminate the review of your application, dated November 2,1998. This is without prejudice to the resubmission of a complete application in case you wish to reactivate the registration in the future.
l if you have any questions, please contact me at (301) 415-7904 or Mr. Frederick Sturz at (301) 415-7273.
- Singely, John P. Jankovich, Ph.D., Senior Engineer Materials Safety and Inspection Branch Division of Indurtrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards cc: SKimberley, LFDCB Distribution:
IMNS r/f SSD-98-98 SSD 99-22 NE0Lik_.
SSD File # NR 555-D-804-S DOCUMENT NAME: H:\\SSDFILES\\LEFERS\\NR555804. cmp To receive a copy of this document,indcote in the box:
- 4 Copy without Mttechment/ enclosure
- E* = Copy with attachment / enc (. Jure
- N" = No copy OFFICE IMNS jff l c--
NAME Jjankovich/s' DATE 4/IJ /99 OFFICIAL RECORD COPY i
l
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l 9904140292 990413 PDR RC SSD PDR
April 13, 1999 l
l Mr. John J. Munro,111 Chief Executive Officer GammaMed USA 2464 E. Stadium Blvd.
Ann Arbor, MI 48104
Dear Mr. Munro:
This letter is in response to your letter dated March 22,1999, withdrawing yot.r application for reactivation of the Model GammaMed 12it brachytherapy HDR remote afterloader (Registration Certificate NR-555-D-804-S). In accordance with your request, we terminate the review of your application, dated November 2,1998. This is without prejudice to the resubmission of a complete application in case you wish to reactivate the registration in the future, if you have any questions, please contact me at (301) 415-7904 or Mr. Frederick Sturz at (301) 415-7273.
- Singely, John P. Jankovich, Ph.D., Senior Engineer Msterials Safety and inspection Branch Division cfIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety And Safeguards cc: SKimberley, LFDCB Distribution:
IMNS r/f SSD-98-98 SSD-99-22 NE01 SSD File # NR-555-D-804-S DOCUMENT NAME: H:\\SSDFILES\\ LETTERS \\NR555804. cmp T., *..
y.: w. m-i. we m in. w.: c - copy wanout.n. chm.nv.ncio. e - copy wan.n.cnm.nu.ncio.w.
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c-NAME JjankovicWs' DATE 4/!J /99 OFFICIAL RECORD COPY l
l 1
April 13, 1999 Mr. John J. Munro, til Chief Executive Officer GammaMed USA' 2464 E. Stadium Blvd.
l Ann Arbor, MI 48104 l
l
Dear Mr. Munro:
This letter is in response to your letter dated March 22,1999, withdrawing your application for reactivation of the Model GammaMed 12it brachytherapy HDR remote afterloader (Registration Certificate NR-555-D-804-S). In accordance with your request, we terminate the review of your application, dated November 2,1998. This is without prejudice to the resubmission of a complete application in case you wish to reactivate the registration in the future.
If you have any questions, please contact me at (301) 415-7904 or Mr. Frederick Sturz at (301) 415-7273.
- Sitgely, John P. Jankovich, Ph.D., Senior Engineer Materials Safety and Inspection Branch l
Division of Industrial and t
Medical Nuclear Safety i
Office of Nuclear Material Safety And Safeguards cc: SKimberley, LFDCB I
Distribution:
IMNS r/f SSD-98-98 SSD-99-22 NE01 SSD File # NR-555-D-804-S DOCUMENTNAME: H:\\SSDFILEStLETTERS\\NR555804. cmp 1
To receive e copy of this stocument,Indrete in the bos: *C' = Copy without attachment / enclosure
- E' = Copy with ettechment/ enclosure
'N' = No copy OFFICE IMNS W[
c-NAME Jjankovich/ij' DATE 4/!S /99 OFFICIAL RECORD COPY i
I l
Q Y, f{NRC FORM 567 PAGE1 U. S. NUCLEAR REGULATORY COMMISSION 0 83),
REQUEST FOR A SEALED SOURCE OR p.,
DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of all related letters /apphcations and d.g to: The Sealed Source Safety Sect.on, ATTN: Chief,
'l i
OWFN Mail Stop 6 H3. Change the License Tracking System rnilestone to 19 and assign to reviewer code I-5.
NOTE: Retain a copy of this request with the apphcation and back9round flies.
REQUEFIER REGION / LOCATION:
A Anr>70 l} P
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ll l11 lV V
HO LFDCB YELEPHONE NUdGEl '
DATE
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TYPE OF ACTION REQUESTED (Check as appropriate)
CPPUCANTS NAME SOURCE REVIEW AMENDMENT OF N)///?rO REQSTRATION SHEET
.A A
r)
MAa. CONTROL NUMBER (S)
DEVICE REVIEW NUMBER (S)
M-553 h kh-3 LETTER /APPUCATION DATE UCENSE NUMBER (S)
CUSTOM REVIEW JI-D 9R M64 E. 3-todium, /MVd.
c ""'""
Am Atlxe, mr 48/04' FOR SSSS USE ONLY NUMBERS HUMBL "/iSSIGNED FJEVIEWER Yomma. /2%l Intr 98-98 DATE RECEfVED DATl! ASSIGNED DATE TO FEES
//- % - 98
/
/M 98 j
TYPE OF ACTION (Indecate the number of each type)
~
VTCOMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C)
DEVICE (9A)
SOURCE (9D)
DEVICE (9B)
NEW r'E W NEW NEW
] AMENDMENT.
fMENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN NO NO FEES REQUIRED l OTHER (Specity) ('luk ~& loDff Awd A asxinoxf & 3s90.0o TOTAL NUMBER OF N
S_ g g-((/d - [d4 O
Al C
REVIEW HOURS Fj/5 6
(/)
Of I
/CN k F C EN LETTERS
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F C EN CALLS FOR B" LING PURPOSES ONLY j NEW REGISTRATION -
] PRODUCT INACTIVE -
NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY
~
9C U 9D k/L M 9A 98 A
NT RECEftdD CHECK NUMBER d69 0
/Da 2
- AS REouiRED MATANN UPDATED
/ fiO j MATSYS UPDATED DATE OF CHECKi/!>
LOG AS REQUIRED '
APPROVED BY DATE RETURN DATE
( v s A C.,9 I
NMC FORM 66/ (Fe3)
EaEM