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FDA 510(k)

PRIMATRIX DERMAL REPAIR SCAFFOLD

K-Number: K131286 · 2013-08-05

ApplicantTei Biosciences, Inc.
Decision Date2013-08-05
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

PRIMATRIX DERMAL REPAIR SCAFFOLD is the device name listed in this FDA 510(k) record. The listed applicant is Tei Biosciences, Inc.. It received FDA 510(k) clearance on 2013-08-05 under 510(k) number K131286. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMATRIX DERMAL REPAIR SCAFFOLD?

PRIMATRIX DERMAL REPAIR SCAFFOLD is a medical device that received FDA 510(k) clearance on 2013-08-05. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K131286.

When did PRIMATRIX DERMAL REPAIR SCAFFOLD receive FDA 510(k) clearance?

PRIMATRIX DERMAL REPAIR SCAFFOLD received FDA 510(k) clearance on 2013-08-05, under 510(k) number K131286.

Who is the listed applicant for PRIMATRIX DERMAL REPAIR SCAFFOLD?

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

What is the FDA product code for PRIMATRIX DERMAL REPAIR SCAFFOLD?

The FDA product code for PRIMATRIX DERMAL REPAIR SCAFFOLD is KGN.

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Other records listing Tei Biosciences, 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.

K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionK153690PriMatrix Dermal Repair ScaffoldK100261PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLDK083898SURGIMENDK083440PRIMATRIX DERMAL REPAIR SCAFFOLDK071807ORTHOMEND SOFT TISSUE MATRIX

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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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