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FDA 510(k)

FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE

K-Number: K982597 · 1998-08-20

ApplicantJohnson & Johnson Medical, Inc.
Decision Date1998-08-20
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1998-08-20 under 510(k) number K982597. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE?

FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE is a medical device that received FDA 510(k) clearance on 1998-08-20. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K982597.

When did FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE receive FDA 510(k) clearance?

FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE received FDA 510(k) clearance on 1998-08-20, under 510(k) number K982597.

Who is the listed applicant for FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE?

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

What is the FDA product code for FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE?

The FDA product code for FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE is KGN.

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Other records listing Johnson & Johnson Medical, 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.

K001690PROTECTIV SAFETY BLOOD COLLECTION NEEDLEK982641ADVANCED NIBP MODULEK983362NU-GEL * WOUND DRESSINGK974080CRITIKON SOFT BLOOD PRESSURE CUFFK980493I.V. CATHETER SYSTEMK972498OBSERVER * CENTRAL STATION

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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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