Name: Predicase
Price: 199 USD

K-number	K171172
Device name	Skyn Original Polyisoprene Lubricated Male Condom - Flavored
Applicant	Ansell Healthcare Products, LLC
Product code	MOL
Device class	Class II
Decision date	Aug 2, 2017
Decision	Substantially Equivalent
Regulation	884.5300

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Skyn Original Polyisoprene Lubricated Male Condom - Flavored

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