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FDA 510(k)

OASIS WOUND MATRIX

K-Number: K061711 · 2006-07-19

ApplicantCook Biotech, Inc.
Decision Date2006-07-19
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

OASIS WOUND MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech, Inc.. It received FDA 510(k) clearance on 2006-07-19 under 510(k) number K061711. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OASIS WOUND MATRIX?

OASIS WOUND MATRIX is a medical device that received FDA 510(k) clearance on 2006-07-19. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K061711.

When did OASIS WOUND MATRIX receive FDA 510(k) clearance?

OASIS WOUND MATRIX received FDA 510(k) clearance on 2006-07-19, under 510(k) number K061711.

Who is the listed applicant for OASIS WOUND MATRIX?

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

What is the FDA product code for OASIS WOUND MATRIX?

The FDA product code for OASIS WOUND MATRIX 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

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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