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FDA 510(k)

COLACTIVE COLLAGEN WOUND DRESSING

K-Number: K050177 · 2005-04-27

ApplicantCovalontechnologies, Inc.
Decision Date2005-04-27
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

COLACTIVE COLLAGEN WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Covalontechnologies, Inc.. It received FDA 510(k) clearance on 2005-04-27 under 510(k) number K050177. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLACTIVE COLLAGEN WOUND DRESSING?

COLACTIVE COLLAGEN WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2005-04-27. The listed applicant is Covalontechnologies, Inc.. The 510(k) number is K050177.

When did COLACTIVE COLLAGEN WOUND DRESSING receive FDA 510(k) clearance?

COLACTIVE COLLAGEN WOUND DRESSING received FDA 510(k) clearance on 2005-04-27, under 510(k) number K050177.

Who is the listed applicant for COLACTIVE COLLAGEN WOUND DRESSING?

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

What is the FDA product code for COLACTIVE COLLAGEN WOUND DRESSING?

The FDA product code for COLACTIVE COLLAGEN WOUND DRESSING is KGN.

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Other records listing Covalontechnologies, 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.

K163556MediClear PreOpK121819SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVERK112549IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVERK043296COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL 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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