Name: Predicase
Price: 199 USD

K-number	K161195
Device name	Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
Applicant	M3 Global Enterprises, LLC
Product code	HIS
Device class	Class II
Decision date	Aug 25, 2016
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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Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)

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