OSTEOTOMY DRAINAGE TUBE

Catheter, Ventricular, General & Plastic Surgery

TREACE MEDICAL, INC.

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

Pre-market Notification Details

Device IDK862584
510k NumberK862584
Device Name:OSTEOTOMY DRAINAGE TUBE
ClassificationCatheter, Ventricular, General & Plastic Surgery
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 CodeGBS  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-07
Decision Date1986-08-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.