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FDA 510(k)

SIGNADRESS DUODERM DRESSING

K-Number: K990964 · 1999-05-18

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1999-05-18
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

SIGNADRESS DUODERM DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1999-05-18 under 510(k) number K990964. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNADRESS DUODERM DRESSING?

SIGNADRESS DUODERM DRESSING is a medical device that received FDA 510(k) clearance on 1999-05-18. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K990964.

When did SIGNADRESS DUODERM DRESSING receive FDA 510(k) clearance?

SIGNADRESS DUODERM DRESSING received FDA 510(k) clearance on 1999-05-18, under 510(k) number K990964.

Who is the listed applicant for SIGNADRESS DUODERM DRESSING?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNADRESS DUODERM DRESSING?

The FDA product code for SIGNADRESS DUODERM DRESSING is KGN.

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Other records listing Convatec, A Division of E.R. Squibb & Sons 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.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN DRESSINGK974205KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON

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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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