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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 K062298
Device Name APOLLO GAMMA CAMERA SYSTEM
Applicant
Adac Laboratories
540 Alder Dr.
Milpitas,  CA  95035
Applicant Contact ANNIE WRIGHT
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131 -1230
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/08/2006
Decision Date 08/23/2006
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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