FDA 510(k)

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)

Numéro K : K180764 · 2018-08-01

Date de décision2018-08-01

Code produitNUC

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is the device name listed in this FDA 510(k) record. The listed applicant is Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2018-08-01 under 510(k) number K180764. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)?

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K180764.

When did TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) receive FDA 510(k) clearance?

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) received FDA 510(k) clearance on 2018-08-01, under 510(k) number K180764.

Who is the listed applicant for TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)?

The FDA 510(k) record lists Church & Dwight Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)?

The FDA product code for TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is NUC.

Essais cliniques associés

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Source officielle

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