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510(k) K243990

BondEase 2 Topical Skin Adhesive by Optmed, Inc. — Product Code MPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2025
Date Received
December 26, 2024
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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