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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K990050
Device Name URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042
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
FGB  
Date Received01/07/1999
Decision Date 03/26/1999
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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