PLIASURE Polyglycolide Synthetic Absorbable 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 Pliasure Polyglycolide Synthetic Absorbable Suture.

Pre-market Notification Details

Device IDK142822
510k NumberK142822
Device Name:PLIASURE Polyglycolide Synthetic Absorbable Suture
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant ETHICON, Inc. Rt. 22 West, P.O. Box 151 Somerville,  NJ  08876
ContactSusan Lin
CorrespondentSusan Lin
ETHICON, Inc. Rt. 22 West, P.O. Box 151 Somerville,  NJ  08876
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-30
Decision Date2015-03-26
Summary:summary

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