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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K891131
Device Name GAMMAMED 12I
Applicant
Mick Radio-Nuclear Instruments, Inc.
P.O. Box 99
Bronx,  NY  10465
Applicant Contact FELIX W MICK
Correspondent
Mick Radio-Nuclear Instruments, Inc.
P.O. Box 99
Bronx,  NY  10465
Correspondent Contact FELIX W MICK
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received03/03/1989
Decision Date 08/07/1989
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
Recalls CDRH Recalls
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