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FDA 510(k)

ALLEVYN ISLAND WOUND DRESSING

K-Number: K935705 · 1994-02-15

ApplicantSmith & Nephew United, Inc.
Decision Date1994-02-15
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALLEVYN ISLAND WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew United, Inc.. It received FDA 510(k) clearance on 1994-02-15 under 510(k) number K935705. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEVYN ISLAND WOUND DRESSING?

ALLEVYN ISLAND WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1994-02-15. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K935705.

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

ALLEVYN ISLAND WOUND DRESSING received FDA 510(k) clearance on 1994-02-15, under 510(k) number K935705.

Who is the listed applicant for ALLEVYN ISLAND WOUND DRESSING?

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

What is the FDA product code for ALLEVYN ISLAND WOUND DRESSING?

The FDA product code for ALLEVYN ISLAND WOUND DRESSING is NAE.

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Other records listing Smith & Nephew United, 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.

K963096ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSINGK961775PROFORE FOUR-LAYER BANDAGE SYSTEM KITK945330ALLEVYN ADHESIVEK943619CAVI-CARE CONFORMING FOAM DRESSINGK942748INTRASITEK935803CICA-CARE SILICONE GEL SHEET

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Related Devices (Code: NAE)

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.

K083721MODIFICATION TO ZENIEVARiver'S Edge Pharmaceuticals, LLCK082865MODIFICATION TO ZENIEVAGorbec Pharmaceutical Services, Inc.K073246ZENIEVAGorbec Pharmaceutical Services, Inc.K992094GILTECH PLUS HYDROGEL SKIN DRESSINGGiltech Plus, Inc.K991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical Products

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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