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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K953438
Device Name SURGICAL INTEGRATED CAMERA SYSTEM
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 Number876.1500
Classification Product Code
GCJ  
Date Received07/21/1995
Decision Date 11/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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