FDA 510(k)

Bloomi Delight Oil-Based Personal Lubricant

K-Number: K222175 · 2022-11-15

Decision Date2022-11-15

Product CodeNUC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Bloomi Delight Oil-Based Personal Lubricant is a medical device manufactured by The Bloomi Inc... It received FDA 510(k) clearance on 2022-11-15 under approval number K222175. 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 Bloomi Delight Oil-Based Personal Lubricant?

Bloomi Delight Oil-Based Personal Lubricant is a medical device that received FDA 510(k) clearance on 2022-11-15. It is manufactured by The Bloomi Inc... The 510(k) number is K222175.

When was Bloomi Delight Oil-Based Personal Lubricant approved by the FDA?

Bloomi Delight Oil-Based Personal Lubricant received FDA 510(k) clearance on 2022-11-15, under approval number K222175.

What company makes Bloomi Delight Oil-Based Personal Lubricant?

Bloomi Delight Oil-Based Personal Lubricant is manufactured by The Bloomi Inc...

What is the FDA product code for Bloomi Delight Oil-Based Personal Lubricant?

The FDA product code for Bloomi Delight Oil-Based Personal Lubricant is NUC.

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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.