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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomographic, Nuclear
510(k) Number K850885
Device Name STARCAM DATA ACQUISITION & PROCESSING SYS H3300C
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact HOWARD II
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact HOWARD II
Regulation Number892.1310
Classification Product Code
JWM  
Date Received03/04/1985
Decision Date 06/06/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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