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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 the device name listed in this FDA 510(k) record. The listed applicant is M3 Global Enterprises, LLC. It received FDA 510(k) clearance on 2016-08-25 under 510(k) 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. The listed applicant is M3 Global Enterprises, LLC. The 510(k) number is K161195.

When did Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) receive FDA 510(k) clearance?

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

Who is the listed applicant for Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)?

The FDA 510(k) record lists M3 Global Enterprises, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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