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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K943435
Device Name CHOLANGIOGRAPHY SET
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
GCJ  
Date Received07/18/1994
Decision Date 11/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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