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FDA 510(k)

DUMEX WET DRESSINGS

K-Number: K950132 · 1995-03-01

ApplicantDumex Medical Surgical Products, Ltd.
Decision Date1995-03-01
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

DUMEX WET DRESSINGS 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 1995-03-01 under 510(k) number K950132. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DUMEX WET DRESSINGS?

DUMEX WET DRESSINGS is a medical device that received FDA 510(k) clearance on 1995-03-01. The listed applicant is Dumex Medical Surgical Products, Ltd.. The 510(k) number is K950132.

When did DUMEX WET DRESSINGS receive FDA 510(k) clearance?

DUMEX WET DRESSINGS received FDA 510(k) clearance on 1995-03-01, under 510(k) number K950132.

Who is the listed applicant for DUMEX WET DRESSINGS?

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 DUMEX WET DRESSINGS?

The FDA product code for DUMEX WET DRESSINGS is FRO. This falls under the Anesthesiology category.

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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)

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Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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