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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 K041218
Device Name GRIFFIN SPECT/CT IMAGING SYSTEM
Applicant
ADAC LABORATORIES
540 ALDER DR.
MILPITAS,  CA  95035
Applicant Contact COLEEN A COLEMAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
1655 SCOTT BLVD.
SANTA CLARA,  CA  95050
Correspondent Contact DENISE LEUNG KLINKER
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received05/10/2004
Decision Date 05/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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