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FDA 510(k)

BURNFREE BURNSOOTHE HYDROGEL

K-Number: K943728 · 1994-09-27

ApplicantLevtrade Intl. (Pty) , Ltd.
Decision Date1994-09-27
Product CodeMGQ
DecisionSubstantially Equivalent for Some Indications

Device Summary

BURNFREE BURNSOOTHE HYDROGEL is the device name listed in this FDA 510(k) record. The listed applicant is Levtrade Intl. (Pty) , Ltd.. It received FDA 510(k) clearance on 1994-09-27 under 510(k) number K943728. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BURNFREE BURNSOOTHE HYDROGEL?

BURNFREE BURNSOOTHE HYDROGEL is a medical device that received FDA 510(k) clearance on 1994-09-27. The listed applicant is Levtrade Intl. (Pty) , Ltd.. The 510(k) number is K943728.

When did BURNFREE BURNSOOTHE HYDROGEL receive FDA 510(k) clearance?

BURNFREE BURNSOOTHE HYDROGEL received FDA 510(k) clearance on 1994-09-27, under 510(k) number K943728.

Who is the listed applicant for BURNFREE BURNSOOTHE HYDROGEL?

The FDA 510(k) record lists Levtrade Intl. (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BURNFREE BURNSOOTHE HYDROGEL?

The FDA product code for BURNFREE BURNSOOTHE HYDROGEL is MGQ.

Related Clinical Trials

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.

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Other records listing Levtrade Intl. (Pty) , 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.

K943470BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTSK921470BURNSHIELD FIRE BLANKETK921471BURNSHIELD TRAUMA DRESSING

Related Devices (Code: MGQ)

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.

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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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