FDA 510(k)

LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT

K-Number: K122477 · 2013-02-19

ApplicantAnsell Healthcare Products, LLC

Decision Date2013-02-19

Product CodeNUC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Healthcare Products, LLC. It received FDA 510(k) clearance on 2013-02-19 under 510(k) number K122477. 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 LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT?

LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT is a medical device that received FDA 510(k) clearance on 2013-02-19. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K122477.

When did LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT receive FDA 510(k) clearance?

LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT received FDA 510(k) clearance on 2013-02-19, under 510(k) number K122477.

Who is the listed applicant for LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT?

The FDA 510(k) record lists Ansell Healthcare Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT?

The FDA product code for LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT is NUC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.