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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name culdoscope (and accessories)
510(k) Number K964276
Device Name ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR
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 Number884.1640
Classification Product Code
HEW  
Subsequent Product Code
HDP  
Date Received10/28/1996
Decision Date 11/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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