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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K952564
Device Name INSPECT/PROSPECT
Applicant
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Applicant Contact RICHARD ZABLOCKI
Correspondent
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Correspondent Contact RICHARD ZABLOCKI
Regulation Number892.1200
Classification Product Code
KPS  
Date Received06/02/1995
Decision Date 11/22/1995
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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