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FDA 510(k)

THALAFIX NATURAL SEA SALT DRESSING

K-Number: K980779 · 1998-06-26

ApplicantDumex Medical Surgical Products, Ltd.
Decision Date1998-06-26
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

THALAFIX NATURAL SEA SALT DRESSING 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 1998-06-26 under 510(k) number K980779. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the THALAFIX NATURAL SEA SALT DRESSING?

THALAFIX NATURAL SEA SALT DRESSING is a medical device that received FDA 510(k) clearance on 1998-06-26. The listed applicant is Dumex Medical Surgical Products, Ltd.. The 510(k) number is K980779.

When did THALAFIX NATURAL SEA SALT DRESSING receive FDA 510(k) clearance?

THALAFIX NATURAL SEA SALT DRESSING received FDA 510(k) clearance on 1998-06-26, under 510(k) number K980779.

Who is the listed applicant for THALAFIX NATURAL SEA SALT DRESSING?

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 THALAFIX NATURAL SEA SALT DRESSING?

The FDA product code for THALAFIX NATURAL SEA SALT DRESSING 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 STRIPK980861DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGELK980863DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)K980777DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING

View all 13 devices →

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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