Exofin High Viscosity Topical Skin Adhesive

Tissue Adhesive For The Topical Approximation Of Skin

Chemence Medical, Inc.

The following data is part of a premarket notification filed by Chemence Medical, Inc. with the FDA for Exofin High Viscosity Topical Skin Adhesive.

Pre-market Notification Details

Device IDK200264
510k NumberK200264
Device Name:Exofin High Viscosity Topical Skin Adhesive
ClassificationTissue Adhesive For The Topical Approximation Of Skin
Applicant Chemence Medical, Inc. 200 Technology Drive Alpharetta,  GA  30005
ContactCharnelle Thomas
CorrespondentCharnelle Thomas
Chemence Medical, Inc. 200 Technology Drive Alpharetta,  GA  30005
Product CodeMPN  
CFR Regulation Number878.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2020-12-17

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