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FDA 510(k)

MESO WOUND MATRIX

K-Number: K112888 · 2012-02-10

ApplicantKensey Nash Corporation
Decision Date2012-02-10
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MESO WOUND MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corporation. It received FDA 510(k) clearance on 2012-02-10 under 510(k) number K112888. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESO WOUND MATRIX?

MESO WOUND MATRIX is a medical device that received FDA 510(k) clearance on 2012-02-10. The listed applicant is Kensey Nash Corporation. The 510(k) number is K112888.

When did MESO WOUND MATRIX receive FDA 510(k) clearance?

MESO WOUND MATRIX received FDA 510(k) clearance on 2012-02-10, under 510(k) number K112888.

Who is the listed applicant for MESO WOUND MATRIX?

The FDA 510(k) record lists Kensey Nash Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MESO WOUND MATRIX?

The FDA product code for MESO WOUND MATRIX is KGN.

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Other records listing Kensey Nash Corporation 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.

K121310MESOTHELIUM DENTAL MEMBRANEK094061KENSEY NASH ECM SURGICAL PATCHK073162SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSINGK060917KENSEY NASH BONE VOID FILLERK061030BIOBLANKET SURGICAL MESH

Related Devices (Code: KGN)

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.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

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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