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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Dose, Radionuclide
510(k) Number K931657
Device Name NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.
Applicant
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130
Applicant Contact ROBERT KOBISTEK
Correspondent
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130
Correspondent Contact ROBERT KOBISTEK
Regulation Number892.1360
Classification Product Code
KPT  
Date Received04/05/1993
Decision Date 07/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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