Exofin Precision Pen

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 Precision Pen.

Pre-market Notification Details

Device IDK212246
510k NumberK212246
Device Name:Exofin Precision Pen
ClassificationTissue Adhesive For The Topical Approximation Of Skin
Applicant Chemence Medical, Inc. 200 Technology Drive Alpharetta,  GA  30115
ContactCharnelle Thomas
CorrespondentCharnelle Thomas
Chemence Medical, Inc. 200 Technology Drive Alpharetta,  GA  30115
Product CodeMPN  
CFR Regulation Number878.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-19
Decision Date2021-09-09

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