FDA 510(k)

LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT

K-Number: K122476 · 2013-03-07

ApplicantAnsell Healthcare Products, LLC

Decision Date2013-03-07

Product CodeNUC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

LIFESTYLES SMOOTH 2-IN-1 MASSAGE & 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 2013-03-07 under 510(k) number K122476. 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 SMOOTH 2-IN-1 MASSAGE & LUBRICANT?

LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT is a medical device that received FDA 510(k) clearance on 2013-03-07. The listed applicant is Ansell Healthcare Products, LLC. The 510(k) number is K122476.

When did LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT receive FDA 510(k) clearance?

LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT received FDA 510(k) clearance on 2013-03-07, under 510(k) number K122476.

Who is the listed applicant for LIFESTYLES SMOOTH 2-IN-1 MASSAGE & 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 SMOOTH 2-IN-1 MASSAGE & LUBRICANT?

The FDA product code for LIFESTYLES SMOOTH 2-IN-1 MASSAGE & 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.