ML20134D317

Advises That,For Products Distributed in Us,Licensee Must Mfg & Distribute Registered Products IAW Statements & Representations Contained in Licensee Applications

ML20134D317
Person / Time
Issue date:	01/31/1997
From:	Michele Burgess NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Gregoire M NORDION INTERNATIONAL, INC.
Shared Package
ML20134D320	List: ML20134D317 ML20134D341
References
SSD, NUDOCS 9702050084
Download: ML20134D317 (1)

Text

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Marc Gregoire . 7 Nordion intemational, Inc. >

447 March Road P.O. Box 13500

' Kanata, Ontario, Canada K2K 1X8 .

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Dear Mr. Gregoire:

We have received notification from Mr. Robert Walker of AECB in Canada that Nordion is proposing a change in design for their radiography sources. This design change involves the use of a " roll pin" or " spring pin" which would be used to connect the source capsule to the pigtail. The proposed design change involve s the integrity of the source assembly. Please be -

advised that, for products distributed within the U.S., you must manufacture and distribute registered products in accordance with the statements and representations contained in your applications, with enclosures thereto, and the information set out in your registration certificates. 1 Please be aware that, before products with the design change can be distributed within the U.S., you must request and obtain an amendment to the appropriate certificates.

If you have any questions, please contact me at (301) 415-5868 or Mr. Steven Baggett at (301) 415-7273.

Sincereiy, OMginal SignedW Michele L. Burgess, Mechanical Engineer Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards

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