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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin
510(k) Number K161011
Device Name SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive
Applicant
Adhezion Biomedical, LLC
One Meridian Blvd., Suite 1b02
Wyomissing,  PA  19610
Applicant Contact Richard Jones
Correspondent
Adhezion Biomedical, LLC
One Meridian Blvd., Suite 1b02
Wyomissing,  PA  19610
Correspondent Contact Richard Jones
Regulation Number878.4010
Classification Product Code
MPN  
Date Received04/11/2016
Decision Date 11/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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