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FDA 510(k)

DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING

K-Number: K980777 · 1998-05-04

ApplicantDumex Medical Surgical Products, Ltd.
Decision Date1998-05-04
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING 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 1998-05-04 under 510(k) number K980777. 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.

Frequently Asked Questions

What is the DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING?

DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING is a medical device that received FDA 510(k) clearance on 1998-05-04. The listed applicant is Dumex Medical Surgical Products, Ltd.. The 510(k) number is K980777.

When did DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING receive FDA 510(k) clearance?

DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING received FDA 510(k) clearance on 1998-05-04, under 510(k) number K980777.

Who is the listed applicant for DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING?

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 PAK-ITS-ABSORBASALT COTTON GAUZE PACKING?

The FDA product code for DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING 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)

View all 13 devices →

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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