FDA 510(k)

BURN JEL PLUS

K-Number: K003396 · 2001-01-11

Decision Date2001-01-11

Product CodeMGQ

DecisionSubstantially Equivalent

Device Summary

BURN JEL PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Water-Jel Technologies, LLC. It received FDA 510(k) clearance on 2001-01-11 under 510(k) number K003396. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURN JEL PLUS?

BURN JEL PLUS is a medical device that received FDA 510(k) clearance on 2001-01-11. The listed applicant is Water-Jel Technologies, LLC. The 510(k) number is K003396.

When did BURN JEL PLUS receive FDA 510(k) clearance?

BURN JEL PLUS received FDA 510(k) clearance on 2001-01-11, under 510(k) number K003396.

Who is the listed applicant for BURN JEL PLUS?

The FDA 510(k) record lists Water-Jel Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BURN JEL PLUS?

The FDA product code for BURN JEL PLUS is MGQ.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.