FDA 510(k)

Personal Lubricating Jelly

Numéro K : K180923 · 2018-07-09

Date de décision2018-07-09

Code produitNUC

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Personal Lubricating Jelly is the device name listed in this FDA 510(k) record. The listed applicant is Perrigo New York, Inc.. It received FDA 510(k) clearance on 2018-07-09 under 510(k) number K180923. 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 Personal Lubricating Jelly?

Personal Lubricating Jelly is a medical device that received FDA 510(k) clearance on 2018-07-09. The listed applicant is Perrigo New York, Inc.. The 510(k) number is K180923.

When did Personal Lubricating Jelly receive FDA 510(k) clearance?

Personal Lubricating Jelly received FDA 510(k) clearance on 2018-07-09, under 510(k) number K180923.

Who is the listed applicant for Personal Lubricating Jelly?

The FDA 510(k) record lists Perrigo New York, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Personal Lubricating Jelly?

The FDA product code for Personal Lubricating Jelly is NUC.

Essais cliniques associés

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Dispositifs connexes (Code : NUC)

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Source officielle

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