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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Television, Endoscopic, Without Audio
510(k) Number K944707
Device Name ISOLATED CAMERA HEAD
Applicant
ENVISION MEDICAL CORP.
749 WARD DR.
SANTA BARBARA,  CA  93111
Applicant Contact DANIEL P MCGUIRE
Correspondent
ENVISION MEDICAL CORP.
749 WARD DR.
SANTA BARBARA,  CA  93111
Correspondent Contact DANIEL P MCGUIRE
Regulation Number878.4160
Classification Product Code
FWF  
Date Received09/23/1994
Decision Date 10/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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