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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 K892358
Device Name PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER
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 Number892.1200
Classification Product Code
KPS  
Date Received04/06/1989
Decision Date 08/23/1989
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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