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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 K850815
Device Name RADIOISOTOPE CALIBRATOR MODEL 34-062
Applicant
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Applicant Contact GLASSER
Correspondent
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Correspondent Contact GLASSER
Regulation Number892.1360
Classification Product Code
KPT  
Date Received02/28/1985
Decision Date 08/21/1985
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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