Name: Predicase
Price: 199 USD

K-number	K101098
Device name	REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
Applicant	Lil Drug Store Products, Inc.
Product code	NUC
Device class	Class II
Decision date	Aug 17, 2010
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.