Exofin Fusion Skin Closure System

Cutaneous Tissue Adhesive With Mesh

Chemence Medical, Inc.

The following data is part of a premarket notification filed by Chemence Medical, Inc. with the FDA for Exofin Fusion Skin Closure System.

Pre-market Notification Details

Device IDK191461
510k NumberK191461
Device Name:Exofin Fusion Skin Closure System
ClassificationCutaneous Tissue Adhesive With Mesh
Applicant Chemence Medical, Inc. 200 Technology Drive Alpharetta,  GA  30005
ContactKenneth N Broadley
CorrespondentKenneth N Broadley
Chemence Medical, Inc. 200 Technology Drive Alpharetta,  GA  30005
Product CodeOMD  
CFR Regulation Number878.4011 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-03
Decision Date2020-06-05

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