SURGISEAL TWIST TOPICAL SKIN ADHESIVE

Tissue Adhesive For The Topical Approximation Of Skin

Adhezion Biomedical, LLC

The following data is part of a premarket notification filed by Adhezion Biomedical, Llc with the FDA for Surgiseal Twist Topical Skin Adhesive.

Pre-market Notification Details

Device IDK141215
510k NumberK141215
Device Name:SURGISEAL TWIST TOPICAL SKIN ADHESIVE
ClassificationTissue Adhesive For The Topical Approximation Of Skin
Applicant Adhezion Biomedical, LLC ONE MERIDIAN BOULEVARD SUITE 1B02 Wyomissing,  PA  19610
ContactRichard Jones
CorrespondentRichard Jones
Adhezion Biomedical, LLC ONE MERIDIAN BOULEVARD SUITE 1B02 Wyomissing,  PA  19610
Product CodeMPN  
CFR Regulation Number878.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-12
Decision Date2014-08-21
Summary:summary

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