BIPOL CABLE

Electrosurgical, Cutting & Coagulation & Accessories

TREACE MEDICAL, INC.

The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Bipol Cable.

Pre-market Notification Details

Device IDK863412
510k NumberK863412
Device Name:BIPOL CABLE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis,  TN  38103
ContactWilliam H Thomas,jr
CorrespondentWilliam H Thomas,jr
TREACE MEDICAL, INC. SUITE 400 22 NORTH SECOND STREET Memphis,  TN  38103
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-03
Decision Date1986-10-02

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