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FDA 510(k)

Parkell Desensitizer Gel

K-Number: K191103 · 2019-11-22

ApplicantParkell, Inc.
Decision Date2019-11-22
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Parkell Desensitizer Gel is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) 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. The listed applicant is Parkell, Inc.. The 510(k) number is K191103.

When did Parkell Desensitizer Gel receive FDA 510(k) clearance?

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

Who is the listed applicant for Parkell Desensitizer Gel?

The FDA 510(k) record lists Parkell, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Parkell Desensitizer Gel?

The FDA product code for Parkell Desensitizer Gel is EJK.

Other records listing Parkell, Inc. 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.

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Related Devices (Code: EJK)

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.

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