Deklene MAXX

Suture, Nonabsorbable, Synthetic, Polypropylene

Teleflex Medical

The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Deklene Maxx.

Pre-market Notification Details

Device IDK193530
510k NumberK193530
Device Name:Deklene MAXX
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
Applicant Teleflex Medical 3015 Carrington Mill Blvd Morrisville,  NC  27560
ContactRobin Haden
CorrespondentRobin Haden
Teleflex Medical 3015 Carrington Mill Blvd Morrisville,  NC  27560
Product CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-03-19

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