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FDA 510(k)

Exofin High Viscosity Tissue Adhesive

N.º K: K152476 · 2016-02-09

SolicitanteChemence Medical Products, Inc.
Fecha de decisión2016-02-09
Código de productoMPN
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Exofin High Viscosity Tissue Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Chemence Medical Products, Inc.. It received FDA 510(k) clearance on 2016-02-09 under 510(k) number K152476. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Exofin High Viscosity Tissue Adhesive?

Exofin High Viscosity Tissue Adhesive is a medical device that received FDA 510(k) clearance on 2016-02-09. The listed applicant is Chemence Medical Products, Inc.. The 510(k) number is K152476.

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

Exofin High Viscosity Tissue Adhesive received FDA 510(k) clearance on 2016-02-09, under 510(k) number K152476.

Who is the listed applicant for Exofin High Viscosity Tissue Adhesive?

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

What is the FDA product code for Exofin High Viscosity Tissue Adhesive?

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

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Dispositivos relacionados (Código: MPN)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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