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FDA 510(k)

MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING

K-Number: K040558 · 2004-03-17

ApplicantCollagen Matrix, Inc.
Decision Date2004-03-17
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2004-03-17 under 510(k) number K040558. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING?

MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2004-03-17. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K040558.

When did MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING receive FDA 510(k) clearance?

MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING received FDA 510(k) clearance on 2004-03-17, under 510(k) number K040558.

Who is the listed applicant for MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING?

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

What is the FDA product code for MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING?

The FDA product code for MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING is KGN.

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Other records listing Collagen Matrix, 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.

K251191Collagen Dura Regeneration Membrane - RepairK243071Bovine Dermis Collagen Dermal MatrixK242302RejuvaKnee™ Collagen Meniscus ImplantK233203Soft Tissue Augmentation Resorbable MatrixK240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixK231942Mineral Collagen Composite Bioactive Extra Moldable

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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