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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Battery-Powered And Accessories
510(k) Number K933201
Device Name AESCULAP TROCAR INSTRUMENT SET
Applicant
Aesculap, Inc.
1000 Gateway Blvd.
South San Francisco,  CA  94080
Applicant Contact VICTORIA MACKINNON
Correspondent
Aesculap, Inc.
1000 Gateway Blvd.
South San Francisco,  CA  94080
Correspondent Contact VICTORIA MACKINNON
Regulation Number876.1500
Classification Product Code
GCS  
Date Received07/01/1993
Decision Date 09/13/1993
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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