Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)— 510(k) K161195

Name: FDA 510(k) clearance K161195
Creator: U.S. Food and Drug Administration
Published: 2016-08-25

Substantially Equivalent

M3 Global Enterprises, LLC

FDA 510(k) clearance K161195 for Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors), Substantially Equivalent on 2016-08-25. Applicant: M3 Global Enterprises, LLC. Device class: 2.

Clearance details

Applicant: M3 Global Enterprises, LLC
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2016-04-27
Decision date: 2016-08-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Beavercreek, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.