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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K900689
Device Name MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA
Applicant
Adac Laboratories
540 Alder Dr.
Milpitas,  CA  95035
Applicant Contact LARRY HERNANDEZ
Correspondent
Adac Laboratories
540 Alder Dr.
Milpitas,  CA  95035
Correspondent Contact LARRY HERNANDEZ
Regulation Number892.1100
Classification Product Code
IYX  
Date Received02/13/1990
Decision Date 04/19/1990
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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