PROLENE (Polypropylene) 3D Patch

Mesh, Surgical, Polymeric

Ethicon, Inc.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Prolene (polypropylene) 3d Patch.

Pre-market Notification Details

Device IDK181268
510k NumberK181268
Device Name:PROLENE (Polypropylene) 3D Patch
ClassificationMesh, Surgical, Polymeric
Applicant Ethicon, Inc. Route 22 West P.O Box 151 Somerville,  NJ  08876 -0151
ContactMelina Escobar
CorrespondentMelina Escobar
Ethicon, Inc. Route 22 West P.O Box 151 Somerville,  NJ  08876 -0151
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-14
Decision Date2018-07-26
Summary:summary

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