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FDA 510(k)

SKINTEMP II

K-Number: K122325 · 2012-10-26

ApplicantHuman Biosciences, Inc.
Decision Date2012-10-26
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

SKINTEMP II 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 2012-10-26 under 510(k) number K122325. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKINTEMP II?

SKINTEMP II is a medical device that received FDA 510(k) clearance on 2012-10-26. The listed applicant is Human Biosciences, Inc.. The 510(k) number is K122325.

When did SKINTEMP II receive FDA 510(k) clearance?

SKINTEMP II received FDA 510(k) clearance on 2012-10-26, under 510(k) number K122325.

Who is the listed applicant for SKINTEMP II?

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 SKINTEMP II?

The FDA product code for SKINTEMP II is KGN.

Related Clinical Trials

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.

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Other records listing Human 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.

K213092Cellusheet, Cellufil

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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