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510(k) K130329

SURGISEAL TOPICAL SKIN ADHESIVE by Adhezion Biomedical, LLC — Product Code MPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2013
Date Received
February 11, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Adhesive For The Topical Approximation Of Skin
Device Class
Class II
Regulation Number
878.4010
Review Panel
SU
Submission Type

Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).

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