LIFESTYLES NATURAL 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 Natural Personal Lubricant.

Pre-market Notification Details

Device IDK122054
510k NumberK122054
Device Name:LIFESTYLES NATURAL 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 Received2012-07-13
Decision Date2013-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08859798100346 K122054 000
08859798100674 K122054 000

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