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FDA 510(k)

HEALEX BIOSPONGE WOUND DRESSING

K-Number: K112191 · 2012-06-05

ApplicantBionova Medical, Inc.
Decision Date2012-06-05
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

HEALEX BIOSPONGE WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Bionova Medical, Inc.. It received FDA 510(k) clearance on 2012-06-05 under 510(k) number K112191. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALEX BIOSPONGE WOUND DRESSING?

HEALEX BIOSPONGE WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2012-06-05. The listed applicant is Bionova Medical, Inc.. The 510(k) number is K112191.

When did HEALEX BIOSPONGE WOUND DRESSING receive FDA 510(k) clearance?

HEALEX BIOSPONGE WOUND DRESSING received FDA 510(k) clearance on 2012-06-05, under 510(k) number K112191.

Who is the listed applicant for HEALEX BIOSPONGE WOUND DRESSING?

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

What is the FDA product code for HEALEX BIOSPONGE WOUND DRESSING?

The FDA product code for HEALEX BIOSPONGE WOUND DRESSING is KGN.

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Other records listing Bionova Medical, Inc. as applicant

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K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloK240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoK231937Foundation Dermal Regeneration Scaffold (DRS) SoloK210949Foundation Dermal Regeneration Scaffold (DRS) SoloK123961SENTREX BIOSPONGE MPD

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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