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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 K033254
Device Name FORTE GAMMA CAMERA SYSTEM
Applicant
Adac Laboratories
540 Alder Dr.
Milpitas,  CA  95035
Applicant Contact JOY M SACMAR
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact DENISE LEUNG KLINKER
Regulation Number892.1200
Classification Product Code
KPS  
Date Received10/08/2003
Decision Date 10/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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