Name: Predicase
Price: 199 USD

K-number	K140506
Device name	JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL
Applicant	Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
Product code	NUC
Device class	Class II
Decision date	Apr 17, 2015
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL

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