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FDA 510(k)

NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING

K-Number: K891101 · 1989-04-17

ApplicantSmith & Nephew United, Inc.
Decision Date1989-04-17
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

NON-ABSORBABLE GAUZE, SURGICAL SPONGE & 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 1989-04-17 under 510(k) number K891101. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING?

NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING is a medical device that received FDA 510(k) clearance on 1989-04-17. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K891101.

When did NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING receive FDA 510(k) clearance?

NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING received FDA 510(k) clearance on 1989-04-17, under 510(k) number K891101.

Who is the listed applicant for NON-ABSORBABLE GAUZE, SURGICAL SPONGE & 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 NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING?

The FDA product code for NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING is NAB.

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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 DRESSINGK942748INTRASITEK935705ALLEVYN ISLAND WOUND DRESSING

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Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, 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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