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FDA 510(k)

Exofin High Viscosity Topical Skin Adhesive

K-Number: K200264 · 2020-12-17

ApplicantChemence Medical, Inc.
Decision Date2020-12-17
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Exofin High Viscosity Topical Skin Adhesive 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 2020-12-17 under 510(k) number K200264. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exofin High Viscosity Topical Skin Adhesive?

Exofin High Viscosity Topical Skin Adhesive is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Chemence Medical, Inc.. The 510(k) number is K200264.

When did Exofin High Viscosity Topical Skin Adhesive receive FDA 510(k) clearance?

Exofin High Viscosity Topical Skin Adhesive received FDA 510(k) clearance on 2020-12-17, under 510(k) number K200264.

Who is the listed applicant for Exofin High Viscosity Topical Skin Adhesive?

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 High Viscosity Topical Skin Adhesive?

The FDA product code for Exofin High Viscosity Topical Skin Adhesive is MPN.

Related Clinical Trials

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.

NCT062170813M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Lacerations and IncisionsTERMINATED

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 PenK191461Exofin Fusion Skin Closure SystemK171442Exofin Fusion Skin Closure SystemK162352derma+flex QS High Viscosity Tissue Adhesive

Related Devices (Code: MPN)

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.

K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc.K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant MedicalK234114CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)Okapi Medical, LLC Dba Resivant MedicalK233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical , Ltd.K230981Meriglu Topical Skin AdhesiveM/s. Meril Endo Surgery Private Limited.K212246Exofin Precision PenChemence Medical, Inc.

Official Source

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

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