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FDA 510(k)

DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)

K-Number: K980863 · 1998-05-11

ApplicantDumex Medical Surgical Products, Ltd.
Decision Date1998-05-11
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) 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 1998-05-11 under 510(k) number K980863. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)?

DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) is a medical device that received FDA 510(k) clearance on 1998-05-11. The listed applicant is Dumex Medical Surgical Products, Ltd.. The 510(k) number is K980863.

When did DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) receive FDA 510(k) clearance?

DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) received FDA 510(k) clearance on 1998-05-11, under 510(k) number K980863.

Who is the listed applicant for DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)?

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 NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)?

The FDA product code for DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) is KMF.

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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 HYDROGELK980777DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING

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Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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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