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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 K964258
Device Name INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS,  IL  60061
Applicant Contact ROBERT L CASARSA
Correspondent
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS,  IL  60061
Correspondent Contact ROBERT L CASARSA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/25/1996
Decision Date 01/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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