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FDA 510(k)

MARIGEN WOUND DRESSING

K-Number: K132343 · 2013-10-23

ApplicantKerecis Limited
Decision Date2013-10-23
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MARIGEN WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Kerecis Limited. It received FDA 510(k) clearance on 2013-10-23 under 510(k) number K132343. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARIGEN WOUND DRESSING?

MARIGEN WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2013-10-23. The listed applicant is Kerecis Limited. The 510(k) number is K132343.

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

MARIGEN WOUND DRESSING received FDA 510(k) clearance on 2013-10-23, under 510(k) number K132343.

Who is the listed applicant for MARIGEN WOUND DRESSING?

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

What is the FDA product code for MARIGEN WOUND DRESSING?

The FDA product code for MARIGEN WOUND DRESSING is KGN.

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Other records listing Kerecis Limited 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.

K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusK251844Kerecis SurgiBind (50241)K243843Tendon Protect (50242)K241080Kerecis Parvus (50207)K213231Kerecis SiliconeK202430Kerecis Reconstruct

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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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