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510(k) K161011

SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive by Adhezion Biomedical, LLC — Product Code MPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2016
Date Received
April 11, 2016
Clearance Type
Traditional
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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