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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 K032036
Device Name GEMINI 16
Applicant
Philips Medical Systems (Cleveland), Inc.
595 Miner Rd.
Cleveland,  OH  44143
Applicant Contact CHRISTOF LITTWITZ
Correspondent
Tuv Rheinland OF North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact HEINZ J STENEBERG
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received07/01/2003
Decision Date 07/11/2003
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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