FDA 510(k)

Creme de La Femme Feminine Lubricant

K-Number: K180014 · 2018-12-21

ApplicantCewal, Inc. Dba Premiere Enterprises

Decision Date2018-12-21

Product CodeNUC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Creme de La Femme Feminine Lubricant is a medical device manufactured by Cewal, Inc. Dba Premiere Enterprises. It received FDA 510(k) clearance on 2018-12-21 under approval number K180014. 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 Creme de La Femme Feminine Lubricant?

Creme de La Femme Feminine Lubricant is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Cewal, Inc. Dba Premiere Enterprises. The 510(k) number is K180014.

When was Creme de La Femme Feminine Lubricant approved by the FDA?

Creme de La Femme Feminine Lubricant received FDA 510(k) clearance on 2018-12-21, under approval number K180014.

What company makes Creme de La Femme Feminine Lubricant?

Creme de La Femme Feminine Lubricant is manufactured by Cewal, Inc. Dba Premiere Enterprises.

What is the FDA product code for Creme de La Femme Feminine Lubricant?

The FDA product code for Creme de La Femme Feminine Lubricant is NUC.

Related Devices (Code: NUC)

K161585Mano and Mano Personal LubricantMano and Mano Proprietary Limited K161544Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc. K161385Just Like Me Personal LubricantWtfn-Dba Classic Erotica/Holiday Products K152671Pulse Aloe-ahhToaster Labs, Inc. K152628Pulse H20h!Toaster Labs, Inc. K153372Repagyn vaginal suppositoriesFarma-Derma S.R.L.

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.