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FDA 510(k)

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)

K-Number: K161195 · 2016-08-25

ApplicantM3 Global Enterprises, LLC
Decision Date2016-08-25
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is a medical device manufactured by M3 Global Enterprises, LLC. It received FDA 510(k) clearance on 2016-08-25 under approval number K161195. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)?

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by M3 Global Enterprises, LLC. The 510(k) number is K161195.

When was Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) approved by the FDA?

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) received FDA 510(k) clearance on 2016-08-25, under approval number K161195.

What company makes Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)?

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is manufactured by M3 Global Enterprises, LLC.

What is the FDA product code for Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)?

The FDA product code for Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is HIS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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