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FDA 510(k)

STERILE HYDROGEL

K-Number: K993119 · 1999-11-23

ApplicantDumex Medical Surgical Products, Ltd.
Decision Date1999-11-23
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

STERILE HYDROGEL 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 1999-11-23 under 510(k) number K993119. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE HYDROGEL?

STERILE HYDROGEL is a medical device that received FDA 510(k) clearance on 1999-11-23. The listed applicant is Dumex Medical Surgical Products, Ltd.. The 510(k) number is K993119.

When did STERILE HYDROGEL receive FDA 510(k) clearance?

STERILE HYDROGEL received FDA 510(k) clearance on 1999-11-23, under 510(k) number K993119.

Who is the listed applicant for STERILE HYDROGEL?

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 STERILE HYDROGEL?

The FDA product code for STERILE HYDROGEL is MGQ.

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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 CHLORIDEK990332DUMEX 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)K980777DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING

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Related Devices (Code: MGQ)

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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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