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FDA 510(k)

REPLIDERM WOUND DRESSING

K-Number: K963228 · 1996-12-18

ApplicantOrphan Medical, Inc.
Decision Date1996-12-18
Product CodeKGN
DecisionSubstantially Equivalent for Some Indications

Device Summary

REPLIDERM WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Orphan Medical, Inc.. It received FDA 510(k) clearance on 1996-12-18 under 510(k) number K963228. The device is classified under product code KGN. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the REPLIDERM WOUND DRESSING?

REPLIDERM WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1996-12-18. The listed applicant is Orphan Medical, Inc.. The 510(k) number is K963228.

When did REPLIDERM WOUND DRESSING receive FDA 510(k) clearance?

REPLIDERM WOUND DRESSING received FDA 510(k) clearance on 1996-12-18, under 510(k) number K963228.

Who is the listed applicant for REPLIDERM WOUND DRESSING?

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

What is the FDA product code for REPLIDERM WOUND DRESSING?

The FDA product code for REPLIDERM WOUND DRESSING is KGN.

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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

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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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