MONOCRYL PLUS ANTIBACTERIAL SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Monocryl Plus Antibacterial Suture.

Pre-market Notification Details

Device IDK050845
510k NumberK050845
Device Name:MONOCRYL PLUS ANTIBACTERIAL SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant ETHICON, INC. ROUTE 22 WEST P.O.BOX 151 Somerville,  NJ  08876
ContactJennifer M Paine
CorrespondentJennifer M Paine
ETHICON, INC. ROUTE 22 WEST P.O.BOX 151 Somerville,  NJ  08876
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2005-04-04
Decision Date2005-06-29
Summary:summary

NIH GUDID Devices

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