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510(k) K212246

Exofin Precision Pen by Chemence Medical, Inc. — Product Code MPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2021
Date Received
July 19, 2021
Clearance Type
Special
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).

Other clearances by Chemence Medical, Inc.

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  • K171442 — Exofin Fusion Skin Closure System (September 25, 2017)
  • K162352 — derma+flex QS High Viscosity Tissue Adhesive (December 22, 2016)
  • K050757 — FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUI (February 23, 2006)

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  • K183570 — LiquiBand Plus (March 9, 2020)
  • K162352 — derma+flex QS High Viscosity Tissue Adhesive (December 22, 2016)
  • K161011 — SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISE (November 8, 2016)
  • K161050 — ACTABOND Topical Skin Adhesive (October 4, 2016)