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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K902981
Device Name G.E. FLUOROCON 300 IMAGING SYSTEM
Applicant
Electromek Diagnostic Systems, Inc.
412 Rte. 40 W.
Troy,  IL  62294
Applicant Contact JAMES HENRICHS
Correspondent
Electromek Diagnostic Systems, Inc.
412 Rte. 40 W.
Troy,  IL  62294
Correspondent Contact JAMES HENRICHS
Regulation Number892.1650
Classification Product Code
JAA  
Date Received06/26/1990
Decision Date 11/07/1990
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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