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FDA 510(k)

E-Z DERM BIOSYNTHETIC WOUND DRESSING

K-Number: K935189 · 1994-07-11

ApplicantBrennen Medical, Inc.
Decision Date1994-07-11
Product CodeKGN
DecisionSubstantially Equivalent for Some Indications

Device Summary

E-Z DERM BIOSYNTHETIC WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Brennen Medical, Inc.. It received FDA 510(k) clearance on 1994-07-11 under 510(k) number K935189. The device is classified under product code KGN. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the E-Z DERM BIOSYNTHETIC WOUND DRESSING?

E-Z DERM BIOSYNTHETIC WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1994-07-11. The listed applicant is Brennen Medical, Inc.. The 510(k) number is K935189.

When did E-Z DERM BIOSYNTHETIC WOUND DRESSING receive FDA 510(k) clearance?

E-Z DERM BIOSYNTHETIC WOUND DRESSING received FDA 510(k) clearance on 1994-07-11, under 510(k) number K935189.

Who is the listed applicant for E-Z DERM BIOSYNTHETIC WOUND DRESSING?

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

What is the FDA product code for E-Z DERM BIOSYNTHETIC WOUND DRESSING?

The FDA product code for E-Z DERM BIOSYNTHETIC WOUND DRESSING is KGN.

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Other records listing Brennen 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.

K050086BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSINGK030460MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXK021835BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEXK002077GLUCANPRO CREAMK002078BETA GLUCAN GEL (MACROPRO GEL)K000519GLUCANPRO

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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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