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FDA 510(k)

COLLAGEN SPONGE

K-Number: K092805 · 2010-02-16

ApplicantInnocoll Pharmaceuticals
Decision Date2010-02-16
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

COLLAGEN SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Innocoll Pharmaceuticals. It received FDA 510(k) clearance on 2010-02-16 under 510(k) number K092805. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLAGEN SPONGE?

COLLAGEN SPONGE is a medical device that received FDA 510(k) clearance on 2010-02-16. The listed applicant is Innocoll Pharmaceuticals. The 510(k) number is K092805.

When did COLLAGEN SPONGE receive FDA 510(k) clearance?

COLLAGEN SPONGE received FDA 510(k) clearance on 2010-02-16, under 510(k) number K092805.

Who is the listed applicant for COLLAGEN SPONGE?

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

What is the FDA product code for COLLAGEN SPONGE?

The FDA product code for COLLAGEN SPONGE is KGN.

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Other records listing Innocoll Pharmaceuticals 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.

K120339PROCOLLK100574COLLEXAK081782COLLIEVAK061746COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID

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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