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FDA 510(k)

COLLAGEN WOUND DRESSING

K-Number: K112580 · 2012-06-01

ApplicantDalim Tissen Co., Ltd.
Decision Date2012-06-01
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

COLLAGEN WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Dalim Tissen Co., Ltd.. It received FDA 510(k) clearance on 2012-06-01 under 510(k) number K112580. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLAGEN WOUND DRESSING?

COLLAGEN WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2012-06-01. The listed applicant is Dalim Tissen Co., Ltd.. The 510(k) number is K112580.

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

COLLAGEN WOUND DRESSING received FDA 510(k) clearance on 2012-06-01, under 510(k) number K112580.

Who is the listed applicant for COLLAGEN WOUND DRESSING?

The FDA 510(k) record lists Dalim Tissen Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLLAGEN WOUND DRESSING?

The FDA product code for 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

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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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