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FDA 510(k)

MariGen Wound Extra

K-Number: K190528 · 2019-07-10

ApplicantKerecis Limited
Decision Date2019-07-10
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MariGen Wound Extra is the device name listed in this FDA 510(k) record. The listed applicant is Kerecis Limited. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K190528. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MariGen Wound Extra?

MariGen Wound Extra is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Kerecis Limited. The 510(k) number is K190528.

When did MariGen Wound Extra receive FDA 510(k) clearance?

MariGen Wound Extra received FDA 510(k) clearance on 2019-07-10, under 510(k) number K190528.

Who is the listed applicant for MariGen Wound Extra?

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 Extra?

The FDA product code for MariGen Wound Extra is KGN.

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)K213904Kerecis OralK213231Kerecis Silicone

View all 10 devices →

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.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

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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