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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 K150866
Device Name SURGISEAL Topical Skin Adhesvie
Applicant
Adhezion Biomedical, LLC
One Meridian Blvd., Suite 1b02
Wyomissing,  PA  19610
Applicant Contact TRACY LOFGREN
Correspondent
Adhezion Biomedical, LLC
One Meridian Blvd., Suite 1b02
Wyomissing,  PA  19610
Correspondent Contact TRACY LOFGREN
Regulation Number878.4010
Classification Product Code
MPN  
Date Received04/01/2015
Decision Date 07/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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