Vaginal Moisturizing Gel

Lubricant, Personal

COMBE INCORPORATED

The following data is part of a premarket notification filed by Combe Incorporated with the FDA for Vaginal Moisturizing Gel.

Pre-market Notification Details

Device IDK150615
510k NumberK150615
Device Name:Vaginal Moisturizing Gel
ClassificationLubricant, Personal
Applicant COMBE INCORPORATED 1101 WESTCHESTER AVE. White Plains,  NY  10604
ContactPushpa Rao
CorrespondentPushpa Rao
COMBE INCORPORATED 1101 WESTCHESTER AVE. White Plains,  NY  10604
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-10
Decision Date2015-05-01
Summary:summary

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