ML20148G974
| ML20148G974 | |
| Person / Time | |
|---|---|
| Issue date: | 06/05/1997 |
| From: | Doug Broaddus NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Burnet S ISOTOPEN MEBSYSTEME GMBH (ISOTOPE MEASURING SYSTEMS |
| Shared Package | |
| ML20148G975 | List: |
| References | |
| SSD, NUDOCS 9706090003 | |
| Download: ML20148G974 (2) | |
Text
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M truq p" k UNITED STATES s# j NUCLEAR REGULATORY COMMISSION p 'g WASHINGTON, D.C. 20556-0001
%, * * , e / June 5, 1997 Susan K. Burnet President Isotope Measuring Systems, Inc.
108 Blue Ridge Drive Cranberry Twp., PA 16606 I
Dear Ms. Bumet:
This is in reference to your application, dated March 1,1995, requesting the addition of several designs to the model 5245-XX series on your registratio certificate NR-0375-D-102-S, and several additional" generic" authorizations. The certificate was amended on June 22,1995, to l add model 5245-03 to the series and to include several of the "gereric" authorizations i requested. The folio ving "genw " authorizations, numbered to co 'espond to your March 1, 1996, request, were incorporate 6 in the amended certificate dated June 22,1995: 1, 3, 4, 8 (for the model 5245-03 device only), 9, and 10. By letter, dated June 22,1995, we requested additional information, concerning the remaining devices in the series and the remaining
" generic" authorizations, necessary to continue with our review. Based on the information contained in your application dated March 1,1995, and subsequent letters thereto, we l' determined that the following additional " generic" authorizations, also numbered to correspond to your March 1,1995, request, are acceptable for licensing purposes: 7 (in accordance with the information provided for the 5321 device), and 8 (other metals could be authorized for the model ,
5245-01 device if all environmental conditions are held to the specified limitations). Registration I certificate NR-0375-D-102-S has been amended (copy enclosed) to reflect this.
To date, we have not received sufficient information concerning the modifications to the device ,
to incorporate a two rail design or complete design and description data for the other requested l model designs in the series to perform a complete evelection. We are unable to take additional :
action on this request until you are able to provide the necessary design and descriptive l information. For this reason, we are voiding the remaining parts of this application with no !
further action. This is without prejudice to the resubmission of a complete application.
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and ;
obtain an amendment to the certificate before you make changes or modifications to the ) j information submitted to obtain the certificate. '
/
Please read over the N0 istration certificate in its entirety and notify us immediately of any errors or omissions. You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRC's licensing fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-6096.
llllllllll111lWll13111 9706090003 970605 i PDR RC * !
SSD PDR I
_. _ _m, ._. . . - - _ _ _ . _ . . _ _ . _ . ._ _ . .._. _ _ _ . - _ _ . _ _ _ _ _ .
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i S. Burnet :
If you have any questions, please contact me at (301) 415-5847 or Mr. Steven Baggett at (301) 415-7273.
i Sincerely, ,
ISI .
Douglas A. Broaddus, Mechanical Engineer Sealed Source Safety Section i Medical, Academic, and ;
Commercial Use Safety Branch l Division of Industrial and Medical Nuclear Safety, NMSS
Enclosure:
As stated +
, cc w/ encl: Sandra Kimberley, LFDCB ,
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M Distribution: '
NE01 SSD-95-33 SSSS r/f NR-0375-D-102-S DOCUMENT NAME: C:\WPDOCS\SSDS\NR375102.VD2 :
T* receive a copy of this elocuenent, trulicate in the boa: "C" = Copy without attechmentlenclosure *E' = Copy with attachment / enclosure *N* = No copy OFFICE IMAB g lC l l l l NAME DABropddus DATE 5/p/97 LFFICIAL RECORD COPY u
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