MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH

Mesh, Surgical, Polymeric

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Modification Of Prolene (polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh.

Pre-market Notification Details

Device IDK984220
510k NumberK984220
Device Name:MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
ClassificationMesh, Surgical, Polymeric
Applicant ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville,  NJ  08876
ContactGregory R Jones
CorrespondentGregory R Jones
ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville,  NJ  08876
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-25
Decision Date1999-02-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705031048935 K984220 000

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