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FDA 510(k)

LubriZenzs

K-Number: K242712 · 2025-06-04

ApplicantSk Zen, LLC
Decision Date2025-06-04
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LubriZenzs is a medical device manufactured by Sk Zen, LLC. It received FDA 510(k) clearance on 2025-06-04 under approval number K242712. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LubriZenzs?

LubriZenzs is a medical device that received FDA 510(k) clearance on 2025-06-04. It is manufactured by Sk Zen, LLC. The 510(k) number is K242712.

When was LubriZenzs approved by the FDA?

LubriZenzs received FDA 510(k) clearance on 2025-06-04, under approval number K242712.

What company makes LubriZenzs?

LubriZenzs is manufactured by Sk Zen, LLC.

What is the FDA product code for LubriZenzs?

The FDA product code for LubriZenzs is NUC.

Related Devices (Code: NUC)

Official Source

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