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FDA 510(k)

SKINTEMP, MODIFICATION

K-Number: K925545 · 1993-02-23

ApplicantBiocore
Decision Date1993-02-23
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

SKINTEMP, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Biocore. It received FDA 510(k) clearance on 1993-02-23 under 510(k) number K925545. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKINTEMP, MODIFICATION?

SKINTEMP, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-02-23. The listed applicant is Biocore. The 510(k) number is K925545.

When did SKINTEMP, MODIFICATION receive FDA 510(k) clearance?

SKINTEMP, MODIFICATION received FDA 510(k) clearance on 1993-02-23, under 510(k) number K925545.

Who is the listed applicant for SKINTEMP, MODIFICATION?

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

What is the FDA product code for SKINTEMP, MODIFICATION?

The FDA product code for SKINTEMP, MODIFICATION 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 Biocore 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.

K913023SKINTEMPK910944MEDIFIL

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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