REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035

Lubricant, Personal

LIL DRUG STORE PRODUCTS, INC.

The following data is part of a premarket notification filed by Lil Drug Store Products, Inc. with the FDA for Replens Long-lasting Vaginal Moisturizer (35g Tube With Reusable Applicator) Model: 83035.

Pre-market Notification Details

Device IDK101098
510k NumberK101098
Device Name:REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
ClassificationLubricant, Personal
Applicant LIL DRUG STORE PRODUCTS, INC. 1201 CONTINENTAL PL. N.E. Cedar Rapids,  IA  52402
ContactPatricia Miller
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-04-20
Decision Date2010-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00311917184616 K101098 000
00022600987611 K101098 000
00022600001072 K101098 000

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