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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K903238
Device Name AFGA VIDEO IMAGER, VARIOUS MODELS
Applicant
Enhanced Imaging Technologies, Inc.
One Ramland Rd.
Orangeburg,  NY  10962
Applicant Contact MICHAEL GUSEL
Correspondent
Enhanced Imaging Technologies, Inc.
One Ramland Rd.
Orangeburg,  NY  10962
Correspondent Contact MICHAEL GUSEL
Regulation Number892.2040
Classification Product Code
LMC  
Date Received07/18/1990
Decision Date 11/02/1990
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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