LIFESTYLES LUXE PREMIUM PERSONAL 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 Luxe Premium Personal Lubricant.

Pre-market Notification Details

Device IDK122477
510k NumberK122477
Device Name:LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
ClassificationLubricant, Personal
Applicant ANSELL HEALTHCARE PRODUCTS LLC 4 LOS VERDES DRIVE San Luis Obispo,  CA  93401
ContactDonna Digangi
CorrespondentDonna Digangi
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 Date2013-02-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18859798101210 K122477 000
08859798101251 K122477 000
08859798101244 K122477 000

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