DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive

Tissue Adhesive For The Topical Approximation Of Skin

Ethicon, Inc.

The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Dermabond Advanced Topical Skin Adhesive, High Viscosity Dermabond Mini Topical Skin Adhesive.

Pre-market Notification Details

Device IDK152096
510k NumberK152096
Device Name:DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive
ClassificationTissue Adhesive For The Topical Approximation Of Skin
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 CodeMPN  
CFR Regulation Number878.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-28
Decision Date2015-10-22
Summary:summary

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