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FDA 510(k)

BRIDGE EXTRACELLULAR COLLEGEN MATRIX

K-Number: K122502 · 2013-02-26

ApplicantHarbor Medtech, Inc.
Decision Date2013-02-26
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

BRIDGE EXTRACELLULAR COLLEGEN MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Harbor Medtech, Inc.. It received FDA 510(k) clearance on 2013-02-26 under 510(k) number K122502. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIDGE EXTRACELLULAR COLLEGEN MATRIX?

BRIDGE EXTRACELLULAR COLLEGEN MATRIX is a medical device that received FDA 510(k) clearance on 2013-02-26. The listed applicant is Harbor Medtech, Inc.. The 510(k) number is K122502.

When did BRIDGE EXTRACELLULAR COLLEGEN MATRIX receive FDA 510(k) clearance?

BRIDGE EXTRACELLULAR COLLEGEN MATRIX received FDA 510(k) clearance on 2013-02-26, under 510(k) number K122502.

Who is the listed applicant for BRIDGE EXTRACELLULAR COLLEGEN MATRIX?

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

What is the FDA product code for BRIDGE EXTRACELLULAR COLLEGEN MATRIX?

The FDA product code for BRIDGE EXTRACELLULAR COLLEGEN MATRIX is KGN.

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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

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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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