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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, Surgical, Without Audio
510(k) Number K934092
Device Name CAMERA, SURGICAL AND ACCESSORIES
Applicant
ENVISION MEDICAL CORP.
7220 HOLLISTER AVE.
GOLETA,  CA  93117
Applicant Contact DANIEL P MCGUIRE
Correspondent
ENVISION MEDICAL CORP.
7220 HOLLISTER AVE.
GOLETA,  CA  93117
Correspondent Contact DANIEL P MCGUIRE
Regulation Number878.4160
Classification Product Code
FWB  
Subsequent Product Code
GCJ  
Date Received08/23/1993
Decision Date 01/07/1994
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
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