ONEPORT SURGICAL TROCAR SYSTEM

Laparoscope, General & Plastic Surgery

CONMED CORPORATION

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Oneport Surgical Trocar System.

Pre-market Notification Details

Device IDK073009
510k NumberK073009
Device Name:ONEPORT SURGICAL TROCAR SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant CONMED CORPORATION 525 FRENCH RD. Utica,  NY  13502
ContactBrian Killoran
CorrespondentJay Y Kogoma
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-10-25
Decision Date2007-12-07
Summary:summary

NIH GUDID Devices

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