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FDA 510(k)

Cellusheet, Cellufil

K-Number: K213092 · 2021-12-15

ApplicantHuman Biosciences, Inc.
Decision Date2021-12-15
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Cellusheet, Cellufil is the device name listed in this FDA 510(k) record. The listed applicant is Human Biosciences, Inc.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K213092. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cellusheet, Cellufil?

Cellusheet, Cellufil is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Human Biosciences, Inc.. The 510(k) number is K213092.

When did Cellusheet, Cellufil receive FDA 510(k) clearance?

Cellusheet, Cellufil received FDA 510(k) clearance on 2021-12-15, under 510(k) number K213092.

Who is the listed applicant for Cellusheet, Cellufil?

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

What is the FDA product code for Cellusheet, Cellufil?

The FDA product code for Cellusheet, Cellufil is KGN.

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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