FDA 510(k)

MucoLock Oral Gel

K-Number: K203091 · 2021-02-12

Decision Date2021-02-12

Product CodeOLR

DecisionSubstantially Equivalent

Device Summary

MucoLock Oral Gel is the device name listed in this FDA 510(k) record. The listed applicant is Pcca, Inc.. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K203091. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MucoLock Oral Gel?

MucoLock Oral Gel is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is Pcca, Inc.. The 510(k) number is K203091.

When did MucoLock Oral Gel receive FDA 510(k) clearance?

MucoLock Oral Gel received FDA 510(k) clearance on 2021-02-12, under 510(k) number K203091.

Who is the listed applicant for MucoLock Oral Gel?

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

What is the FDA product code for MucoLock Oral Gel?

The FDA product code for MucoLock Oral Gel is OLR.

Other records listing Pcca, 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: OLR)

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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.