LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT

Lubricant, Personal

ANSELL HEALTHCARE PRODUCTS, LLC

The following data is part of a premarket notification filed by Ansell Healthcare Products, Llc with the FDA for Lifestyles Smooth 2-in-1 Massage & Lubricant.

Pre-market Notification Details

Device IDK122476
510k NumberK122476
Device Name:LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
ClassificationLubricant, Personal
Applicant ANSELL HEALTHCARE PRODUCTS, LLC 4 LOS VERDES DRIVE San Luis Obispo,  CA  93401
ContactDonna Di Gangi
CorrespondentDonna Di Gangi
ANSELL HEALTHCARE PRODUCTS, LLC 4 LOS VERDES DRIVE San Luis Obispo,  CA  93401
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-14
Decision Date2013-03-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10070907270056 K122476 000
10070907207427 K122476 000
10070907084011 K122476 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.