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FDA 510(k)

FIBRILLAR COLLAGEN WOUND DRESSING

K-Number: K120250 · 2013-04-21

ApplicantCollafirm, LLC
Decision Date2013-04-21
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

FIBRILLAR COLLAGEN WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Collafirm, LLC. It received FDA 510(k) clearance on 2013-04-21 under 510(k) number K120250. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRILLAR COLLAGEN WOUND DRESSING?

FIBRILLAR COLLAGEN WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2013-04-21. The listed applicant is Collafirm, LLC. The 510(k) number is K120250.

When did FIBRILLAR COLLAGEN WOUND DRESSING receive FDA 510(k) clearance?

FIBRILLAR COLLAGEN WOUND DRESSING received FDA 510(k) clearance on 2013-04-21, under 510(k) number K120250.

Who is the listed applicant for FIBRILLAR COLLAGEN WOUND DRESSING?

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

What is the FDA product code for FIBRILLAR COLLAGEN WOUND DRESSING?

The FDA product code for FIBRILLAR COLLAGEN WOUND DRESSING 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

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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