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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 K073009
Device Name ONEPORT SURGICAL TROCAR SYSTEM
Applicant
CONMED CORPORATION
525 FRENCH RD.
UTICA,  NY  13502
Applicant Contact BRIAN KILLORAN
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/25/2007
Decision Date 12/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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