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FDA 510(k)

COVAGEN

K-Number: K123756 · 2013-08-16

ApplicantCovalon Technologies, Ltd.
Decision Date2013-08-16
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

COVAGEN is the device name listed in this FDA 510(k) record. The listed applicant is Covalon Technologies, Ltd.. It received FDA 510(k) clearance on 2013-08-16 under 510(k) number K123756. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVAGEN?

COVAGEN is a medical device that received FDA 510(k) clearance on 2013-08-16. The listed applicant is Covalon Technologies, Ltd.. The 510(k) number is K123756.

When did COVAGEN receive FDA 510(k) clearance?

COVAGEN received FDA 510(k) clearance on 2013-08-16, under 510(k) number K123756.

Who is the listed applicant for COVAGEN?

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

What is the FDA product code for COVAGEN?

The FDA product code for COVAGEN is KGN.

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Other records listing Covalon Technologies, 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.

K260652ColActive PlusK060804COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSINGK052696COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING

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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