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FDA 510(k)

Exofin Fusion Skin Closure System

K-Number: K171442 · 2017-09-25

ApplicantChemence Medical, Inc.
Decision Date2017-09-25
Product CodeOMD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Exofin Fusion Skin Closure System is the device name listed in this FDA 510(k) record. The listed applicant is Chemence Medical, Inc.. It received FDA 510(k) clearance on 2017-09-25 under 510(k) number K171442. The device is classified under product code OMD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exofin Fusion Skin Closure System?

Exofin Fusion Skin Closure System is a medical device that received FDA 510(k) clearance on 2017-09-25. The listed applicant is Chemence Medical, Inc.. The 510(k) number is K171442.

When did Exofin Fusion Skin Closure System receive FDA 510(k) clearance?

Exofin Fusion Skin Closure System received FDA 510(k) clearance on 2017-09-25, under 510(k) number K171442.

Who is the listed applicant for Exofin Fusion Skin Closure System?

The FDA 510(k) record lists Chemence Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exofin Fusion Skin Closure System?

The FDA product code for Exofin Fusion Skin Closure System is OMD.

Other records listing Chemence Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212246Exofin Precision PenK200264Exofin High Viscosity Topical Skin AdhesiveK191461Exofin Fusion Skin Closure SystemK162352derma+flex QS High Viscosity Tissue Adhesive

Related Devices (Code: OMD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233460CM00622 LINC Skin Closure System (CM00622 LINC)Connexicon Medical , Ltd.K211878LiquiBand XLAdvanced Medical Solutions LimitedK213512DERMABOND PRINEO Skin Closure SystemETHICON, Inc.K191461Exofin Fusion Skin Closure SystemChemence Medical, Inc.K163645DERMABOND PRINEO Skin Closure SystemEthicon, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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