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510(k) K152096

DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive by Ethicon, Inc. — Product Code MPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2015
Date Received
July 28, 2015
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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