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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 K874473
Device Name ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM
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 Received11/02/1987
Decision Date 07/18/1988
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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