TBD ETHICON MESH

Mesh, Surgical, Polymeric

ETHICON INC.

The following data is part of a premarket notification filed by Ethicon Inc. with the FDA for Tbd Ethicon Mesh.

Pre-market Notification Details

Device IDK082216
510k NumberK082216
Device Name:TBD ETHICON MESH
ClassificationMesh, Surgical, Polymeric
Applicant ETHICON INC. ROUTE 22 WEST PO BOX 151 Somerville,  NJ  08876
ContactBryan A Lisa
CorrespondentBryan A Lisa
ETHICON INC. ROUTE 22 WEST PO BOX 151 Somerville,  NJ  08876
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-06
Decision Date2008-09-05
Summary:summary

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