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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Contamination Prevention Sheath
510(k) Number K943697
Device Name TROCARS,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 Number876.1500
Classification Product Code
ODB  
Subsequent Product Codes
FBQ   FEC   GCJ  
Date Received07/29/1994
Decision Date 09/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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