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FDA 510(k)

DUTEX GAUZE BANDAGE

K-Number: K946326 · 1995-01-24

ApplicantDumex Medical Surgical Products, Ltd.
Decision Date1995-01-24
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

DUTEX GAUZE BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Dumex Medical Surgical Products, Ltd.. It received FDA 510(k) clearance on 1995-01-24 under 510(k) number K946326. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUTEX GAUZE BANDAGE?

DUTEX GAUZE BANDAGE is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is Dumex Medical Surgical Products, Ltd.. The 510(k) number is K946326.

When did DUTEX GAUZE BANDAGE receive FDA 510(k) clearance?

DUTEX GAUZE BANDAGE received FDA 510(k) clearance on 1995-01-24, under 510(k) number K946326.

Who is the listed applicant for DUTEX GAUZE BANDAGE?

The FDA 510(k) record lists Dumex Medical Surgical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUTEX GAUZE BANDAGE?

The FDA product code for DUTEX GAUZE BANDAGE is EFQ.

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Other records listing Dumex Medical Surgical Products, Ltd. 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.

K992732STERILE WATER & STERILE 0.9% SODIUM CHLORIDEK993119STERILE HYDROGELK990332DUMEX IODOFORM PACKING STRIPK980779THALAFIX NATURAL SEA SALT DRESSINGK980861DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGELK980863DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)

View all 13 devices →

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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