SURGISEAL 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 Topical Skin Adhesive.

Pre-market Notification Details

Device IDK123936
510k NumberK123936
Device Name:SURGISEAL TOPICAL SKIN ADHESIVE
ClassificationTissue Adhesive For The Topical Approximation Of Skin
Applicant Adhezion Biomedical, LLC ONE MERIDIAN PARKWAY SUITE 1B02 Wyomissing,  PA  19610
ContactCaridad Smith
CorrespondentCaridad Smith
Adhezion Biomedical, LLC ONE MERIDIAN PARKWAY SUITE 1B02 Wyomissing,  PA  19610
Product CodeMPN  
CFR Regulation Number878.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-20
Decision Date2013-04-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.