DemeDIOX Barbed Absorbable Surgical Suture

Suture, Surgical, Absorbable, Polydioxanone

DemeTECH Corporation

The following data is part of a premarket notification filed by Demetech Corporation with the FDA for Demediox Barbed Absorbable Surgical Suture.

Pre-market Notification Details

Device IDK191361
501k NumberK191361
Device Name:DemeDIOX Barbed Absorbable Surgical Suture
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant DemeTECH Corporation 14175 NW 60th Ave Miami Lakes,  FL  33014
ContactTracy Chadwrick
CorrespondentTracy Chadwrick
DemeTECH Corporation 14175 NW 60th Ave Miami Lakes,  FL  33014
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
501k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-21
Decision Date2019-11-07

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