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FDA 510(k)

THERAFORM STANDARD/SHEET

K-Number: K090812 · 2009-07-30

ApplicantSewon Cellontech Co., Ltd.
Decision Date2009-07-30
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

THERAFORM STANDARD/SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Sewon Cellontech Co., Ltd.. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K090812. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAFORM STANDARD/SHEET?

THERAFORM STANDARD/SHEET is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Sewon Cellontech Co., Ltd.. The 510(k) number is K090812.

When did THERAFORM STANDARD/SHEET receive FDA 510(k) clearance?

THERAFORM STANDARD/SHEET received FDA 510(k) clearance on 2009-07-30, under 510(k) number K090812.

Who is the listed applicant for THERAFORM STANDARD/SHEET?

The FDA 510(k) record lists Sewon Cellontech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERAFORM STANDARD/SHEET?

The FDA product code for THERAFORM STANDARD/SHEET 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 Sewon Cellontech Co., Ltd. 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.

K090823THERAFORM BILAYER

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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