DERMABOND PRINEO SKIN CLOSURE SYSTEM

Cutaneous Tissue Adhesive With Mesh

ETHICON, INC.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Dermabond Prineo Skin Closure System.

Pre-market Notification Details

Device IDK133864
510k NumberK133864
Device Name:DERMABOND PRINEO SKIN CLOSURE SYSTEM
ClassificationCutaneous Tissue Adhesive With Mesh
Applicant ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville,  NJ  08876 -0151
ContactDonna Marshall
CorrespondentDonna Marshall
ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville,  NJ  08876 -0151
Product CodeOMD  
CFR Regulation Number878.4011 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-19
Decision Date2014-03-10
Summary:summary

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