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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 K130474
Device Name SURGISEAL TOPICAL SKIN ADHESIVE
Applicant
Adhezion Biomedical, LLC
One Meridian Pkwy.
Suite 1b02
Wyomissing,  PA  19610
Applicant Contact Caridad Smith
Correspondent
Adhezion Biomedical, LLC
One Meridian Pkwy.
Suite 1b02
Wyomissing,  PA  19610
Correspondent Contact Caridad Smith
Regulation Number878.4010
Classification Product Code
MPN  
Date Received02/25/2013
Decision Date 05/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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