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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 K142464
Device Name Entriport
Applicant
CONMED CORPORATION
525 FRENCH RD.
UTICA,  NY  13502
Applicant Contact Anna D'Lima
Correspondent
CONMED CORPORATION
525 FRENCH RD.
UTICA,  NY  13502
Correspondent Contact Anna D'Lima
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/02/2014
Decision Date 03/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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