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FDA 510(k)

COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID

K-Number: K061746 · 2006-10-02

ApplicantInnocoll Pharmaceuticals
Decision Date2006-10-02
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID is the device name listed in this FDA 510(k) record. The listed applicant is Innocoll Pharmaceuticals. It received FDA 510(k) clearance on 2006-10-02 under 510(k) number K061746. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID?

COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID is a medical device that received FDA 510(k) clearance on 2006-10-02. The listed applicant is Innocoll Pharmaceuticals. The 510(k) number is K061746.

When did COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID receive FDA 510(k) clearance?

COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID received FDA 510(k) clearance on 2006-10-02, under 510(k) number K061746.

Who is the listed applicant for COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID?

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 COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID?

The FDA product code for COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID 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 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.

K120339PROCOLLK100574COLLEXAK092805COLLAGEN SPONGEK081782COLLIEVA

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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