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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K960640
Device Name S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
Applicant
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
8305 MELROSE DR.
LENEXA,  KS  66214
Applicant Contact JAY SULLIVAN
Correspondent
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
8305 MELROSE DR.
LENEXA,  KS  66214
Correspondent Contact JAY SULLIVAN
Regulation Number884.1720
Classification Product Code
HET  
Date Received02/12/1996
Decision Date 02/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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