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FDA 510(k)

UNITE BIOMATRIX

K-Number: K071425 · 2007-06-20

ApplicantPegasus Biologics, Inc.
Decision Date2007-06-20
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

UNITE BIOMATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Pegasus Biologics, Inc.. It received FDA 510(k) clearance on 2007-06-20 under 510(k) number K071425. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITE BIOMATRIX?

UNITE BIOMATRIX is a medical device that received FDA 510(k) clearance on 2007-06-20. The listed applicant is Pegasus Biologics, Inc.. The 510(k) number is K071425.

When did UNITE BIOMATRIX receive FDA 510(k) clearance?

UNITE BIOMATRIX received FDA 510(k) clearance on 2007-06-20, under 510(k) number K071425.

Who is the listed applicant for UNITE BIOMATRIX?

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

What is the FDA product code for UNITE BIOMATRIX?

The FDA product code for UNITE BIOMATRIX is KGN.

Related Clinical Trials

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Other records listing Pegasus Biologics, Inc. 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.

K090288ORTHADAPT PRK071065ORTHADAPT BIOIMPLANTK061494DERMADAPT WOUND DRESSINGK043388PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH

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

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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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