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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomographic, nuclear
510(k) Number K873075
Device Name ADAC MODEL ARC-5000, GAMMA CAMERA
Applicant
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Applicant Contact GARY L PEMBROKE
Correspondent
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Correspondent Contact GARY L PEMBROKE
Regulation Number892.1310
Classification Product Code
JWM  
Date Received08/06/1987
Decision Date 10/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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