ML20054G376

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Requests Evidence That Procurement Preparation & Use of Matl Will Be in Accordance W/Federal Food,Drug & Cosmetic Act & Public Health Svc Act
ML20054G376
Person / Time
Issue date: 05/06/1976
From: Bowyer J
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Vincent N
ST. VINCENTS MEDICAL CENTER, BRIDGEPORT, CT
Shared Package
ML20054G353 List:
References
FRN-47FR15801, RULE-PR-50 NUDOCS 8206210500
Download: ML20054G376 (1)


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NUCLEAR REGULATORY COMMISSION P

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1376 FCMS:RLB JEB (71607) 1 St. Vircint's Hospital ATTN:

Nonnan R. Vincent, M.D.

Department of Nuclear Medicine 2820 Main Street Bridgeport, Connecticut 06606 Gentlemen:

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In support of your application to use Tc99M sulphur colloid to assess the intracavity distribution of P-32 chromic phosphate and Tc99M pyrophosphate for myocardial -imagery you should submit evidence that your procurement, preparation and use of this material will be in accordance with the Federal Food, Drug and Cosmetic Act O

and the Public Health Service Act, or that they are exempt from these acts.

We will continue our review of your application upon receipt of this information.

Please refer to Control No. 71607 in your reply.

Sincerely, J

o er Radioisotopes Licensing Branch Division of Fuel Cycle and Material Safety y 6:t J 6

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