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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 K943713
Device Name TORCARS,CANNULAE,SHEATHS,OBTURATORS
Applicant
Karl Storz Endoskop GmbH
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact MARIKA ANDERSON
Correspondent
Karl Storz Endoskop GmbH
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact MARIKA ANDERSON
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Code
HIH  
Date Received08/01/1994
Decision Date 06/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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