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FDA 510(k)

PROFORE FOUR-LAYER BANDAGE SYSTEM KIT

K-Number: K961775 · 1996-07-16

ApplicantSmith & Nephew United, Inc.
Decision Date1996-07-16
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

PROFORE FOUR-LAYER BANDAGE SYSTEM KIT 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 1996-07-16 under 510(k) number K961775. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFORE FOUR-LAYER BANDAGE SYSTEM KIT?

PROFORE FOUR-LAYER BANDAGE SYSTEM KIT is a medical device that received FDA 510(k) clearance on 1996-07-16. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K961775.

When did PROFORE FOUR-LAYER BANDAGE SYSTEM KIT receive FDA 510(k) clearance?

PROFORE FOUR-LAYER BANDAGE SYSTEM KIT received FDA 510(k) clearance on 1996-07-16, under 510(k) number K961775.

Who is the listed applicant for PROFORE FOUR-LAYER BANDAGE SYSTEM KIT?

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 PROFORE FOUR-LAYER BANDAGE SYSTEM KIT?

The FDA product code for PROFORE FOUR-LAYER BANDAGE SYSTEM KIT is EFQ.

Related Clinical Trials

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.

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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 DRESSINGK945330ALLEVYN ADHESIVEK943619CAVI-CARE CONFORMING FOAM DRESSINGK942748INTRASITEK935705ALLEVYN ISLAND WOUND DRESSINGK935803CICA-CARE SILICONE GEL SHEET

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Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, 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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