FDA 510(k)

Parkell Desensitizer Gel

K-Number: K191103 · 2019-11-22

Decision Date2019-11-22

Product CodeEJK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Parkell Desensitizer Gel is a medical device manufactured by Parkell, Inc.. It received FDA 510(k) clearance on 2019-11-22 under approval number K191103. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Parkell Desensitizer Gel?

Parkell Desensitizer Gel is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Parkell, Inc.. The 510(k) number is K191103.

When was Parkell Desensitizer Gel approved by the FDA?

Parkell Desensitizer Gel received FDA 510(k) clearance on 2019-11-22, under approval number K191103.

What company makes Parkell Desensitizer Gel?

Parkell Desensitizer Gel is manufactured by Parkell, Inc..

What is the FDA product code for Parkell Desensitizer Gel?

The FDA product code for Parkell Desensitizer Gel is EJK.

Other Devices by Parkell, Inc.

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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.