ML012320007
| ML012320007 | |
| Person / Time | |
|---|---|
| Issue date: | 08/20/2001 |
| From: | Samson Lee NRC/NMSS/IMNS/MSIB |
| To: | Burbach K Sensor Applications |
| References | |
| SSD 01-27 | |
| Download: ML012320007 (3) | |
Text
Sensor Applications Inc.
ENCLOSURE We are in the process of reviewing your application for the Model M90 chemical detector unit.
In order to continue our review, we need the following information:
1.
Please clarify the radioactive source model to be used in the Model M90. Item F of Summary Data, AMM 2 was specified for the radioactive source model, instead of AMM as approved in your previous registration certificate number NR-174-D-101-E. However, that particular source model can not be located in the National Sealed Source and Device Registry System. If the AMM 2 is not currently registered, you must register it separately or a part of the application. In either case, you must submit sufficient information to register the AMM 2 sealed source.
2.
Please clarify the radiation level of 30 rem/hr as shown in Page 2 of your application.
3.
Please provide the complete engineering drawings of the sensor unit module and basic assembly drawings of the complete product.
4.
Please provide tamper-proof hardwares specifications and their locations.
5.
Please provide the descriptions of the label for point-of-sale packages, which should be equivalent to 10 CFR 32.29(b)(3).
6.
Three (3) attachments to Finnish Centre for Radiation and Nuclear Safety report dated July 21, 1994, for radiation profiles specified in Page 12 of your application are missing.
Please provide them.
7.
Please provide a copy of ISO 9001 certificate for Environics, Oy.
8.
Please provide Sensor Applications Inc.s QA/QC audit frequency and procedures for Environics, Oy.
Kenneth E. Burbach, President Sensor Applications Inc.
737 Walker Road, Suite 1 P.O. Box 439 Great Falls, VA 22066
SUBJECT:
REQUEST FOR ADDITIONAL INFORMATION ON MODEL M90:
Dear Mr. Burbuch:
This letter is in response to your application dated May 11, 2001, requesting sealed source and device safety evaluation and registration of your M90 Envirionics Chemical Detector Unit. We are in the process of evaluating your request. In order to continue our evaluation, we need additional information attached in the Enclosure.
Please submit the requested information within thirty days of the date of this letter. If we have not received complete information within thirty days of the date of this letter, we will consider your application as having been abandoned by you. This is without prejudice to the resubmission of a complete application.
If you have any questions, please contact me at (301) 415-5787 or Ms. Michele Burgess at (301) 415-5868.
Sincerely, Seung J. Lee, Mechanical Engineer Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated Distribution:
MSIB r/f IMNS r/f SSD-01-27 File Name: K:\\Document Processing Center_Ascent\\ADAMSP8-2039\\downloads\\001 -
100\\052\\ML012320007.wpd To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy OFFICE MSIB E MSIB NAME SLee MBurgess DATE 06/18/01 06/ /01 OFFICIAL RECORD COPY
Kenneth E. Burbach, President Sensor Applications Inc.
737 Walker Road, Suite 1 P.O. Box 439 Great Falls, VA 22066
SUBJECT:
REQUEST FOR ADDITIONAL INFORMATION ON MODEL M90:
Dear Mr. Burbuch:
This letter is in response to your application dated May 11, 2001, requesting sealed source and device safety evaluation and registration of your M90 Envirionics Chemical Detector Unit. We are in the process of evaluating your request. In order to continue our evaluation, we need additional information attached in the Enclosure.
Please submit the requested information within thirty days of the date of this letter. If we have not received complete information within thirty days of the date of this letter, we will consider your application as having been abandoned by you. This is without prejudice to the resubmission of a complete application.
If you have any questions, please contact me at (301) 415-5787 or Ms. Michele Burgess at (301) 415-5868.
Sincerely, Seung J. Lee, Mechanical Engineer Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated