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FDA 510(k)

MatriDerm

K-Number: K201577 · 2021-01-07

ApplicantMedskin Solutions Dr. Suwelack AG
Decision Date2021-01-07
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MatriDerm is the device name listed in this FDA 510(k) record. The listed applicant is Medskin Solutions Dr. Suwelack AG. It received FDA 510(k) clearance on 2021-01-07 under 510(k) number K201577. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MatriDerm?

MatriDerm is a medical device that received FDA 510(k) clearance on 2021-01-07. The listed applicant is Medskin Solutions Dr. Suwelack AG. The 510(k) number is K201577.

When did MatriDerm receive FDA 510(k) clearance?

MatriDerm received FDA 510(k) clearance on 2021-01-07, under 510(k) number K201577.

Who is the listed applicant for MatriDerm?

The FDA 510(k) record lists Medskin Solutions Dr. Suwelack AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MatriDerm?

The FDA product code for MatriDerm is KGN.

Other records listing Medskin Solutions Dr. Suwelack AG 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.

K261224MatriDermK250864MatriDerm pluS+ Bi-Layer

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

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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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