DemeTECH DemeDIOX 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 Demetech Demediox Absorbable Surgical Suture.

Pre-market Notification Details

Device IDK181582
510k NumberK181582
Device Name:DemeTECH DemeDIOX Absorbable Surgical Suture
ClassificationSuture, Surgical, Absorbable, Polydioxanone
Applicant Demetech Corporation 14175 NW 60th Ave Miami Lakes,  FL  33014
ContactLinda Hernandez
CorrespondentLinda Hernandez
Demetech Corporation 14175 NW 60th Ave Miami Lakes,  FL  33014
Product CodeNEW  
CFR Regulation Number878.4840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-15
Decision Date2018-08-27
Summary:summary

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