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FDA 510(k)

DRESSSKIN

K-Number: K023778 · 2003-09-29

ApplicantTei Biosciences, Inc.
Decision Date2003-09-29
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

DRESSSKIN 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 2003-09-29 under 510(k) number K023778. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRESSSKIN?

DRESSSKIN is a medical device that received FDA 510(k) clearance on 2003-09-29. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K023778.

When did DRESSSKIN receive FDA 510(k) clearance?

DRESSSKIN received FDA 510(k) clearance on 2003-09-29, under 510(k) number K023778.

Who is the listed applicant for DRESSSKIN?

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 DRESSSKIN?

The FDA product code for DRESSSKIN is KGN.

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Other records listing Tei Biosciences, Inc. as applicant

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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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