FDA 510(k)

Mano and Mano Personal Lubricant

K-Number: K161585 · 2016-09-06

ApplicantMano and Mano Proprietary Limited

Decision Date2016-09-06

Product CodeNUC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Mano and Mano Personal Lubricant is a medical device manufactured by Mano and Mano Proprietary Limited. It received FDA 510(k) clearance on 2016-09-06 under approval number K161585. 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 Mano and Mano Personal Lubricant?

Mano and Mano Personal Lubricant is a medical device that received FDA 510(k) clearance on 2016-09-06. It is manufactured by Mano and Mano Proprietary Limited. The 510(k) number is K161585.

When was Mano and Mano Personal Lubricant approved by the FDA?

Mano and Mano Personal Lubricant received FDA 510(k) clearance on 2016-09-06, under approval number K161585.

What company makes Mano and Mano Personal Lubricant?

Mano and Mano Personal Lubricant is manufactured by Mano and Mano Proprietary Limited.

What is the FDA product code for Mano and Mano Personal Lubricant?

The FDA product code for Mano and Mano Personal Lubricant is NUC.

Related Devices (Code: 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.