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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 K082993
Device Name SURGISEAL TOPICAL SKIN ADHESIVE
Applicant
Adhezion Biomedical
506 Pine Mountain Rd.
Hudson,  NC  28638
Applicant Contact RICHARD G JONES
Correspondent
Adhezion Biomedical
506 Pine Mountain Rd.
Hudson,  NC  28638
Correspondent Contact RICHARD G JONES
Regulation Number878.4010
Classification Product Code
MPN  
Date Received10/07/2008
Decision Date 12/19/2008
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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