ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE

Mesh, Surgical, Polymeric

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethicon Physiomesh Open Flexible Composite Mesh Device.

Pre-market Notification Details

Device IDK141560
510k NumberK141560
Device Name:ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
ClassificationMesh, Surgical, Polymeric
Applicant ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville,  NJ  08876 -0151
ContactSusan Lin
CorrespondentSusan Lin
ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville,  NJ  08876 -0151
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-12
Decision Date2014-10-23
Summary:summary

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