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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name choledochoscope and accessories, flexible/rigid
510(k) Number K962172
Device Name FLEXIBLE MINI-FIBERSCOPES
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS,  IL  60061
Applicant Contact ROBERT CASARSA
Correspondent
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS,  IL  60061
Correspondent Contact ROBERT CASARSA
Regulation Number876.1500
Classification Product Code
FBN  
Subsequent Product Codes
FAJ   FAS   FCL   FFL   FGA  
FGB   GCQ   ODC  
Date Received06/05/1996
Decision Date 12/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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