Durex Condom with Benzocaine
K-Number: K211152 · 2022-05-11
ApplicantRb Health (Us), LLC
Decision Date2022-05-11
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Durex Condom with Benzocaine is a medical device manufactured by Rb Health (Us), LLC. It received FDA 510(k) clearance on 2022-05-11 under approval number K211152. 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 Durex Condom with Benzocaine?
Durex Condom with Benzocaine is a medical device that received FDA 510(k) clearance on 2022-05-11. It is manufactured by Rb Health (Us), LLC. The 510(k) number is K211152.
When was Durex Condom with Benzocaine approved by the FDA?
Durex Condom with Benzocaine received FDA 510(k) clearance on 2022-05-11, under approval number K211152.
What company makes Durex Condom with Benzocaine?
Durex Condom with Benzocaine is manufactured by Rb Health (Us), LLC.
What is the FDA product code for Durex Condom with Benzocaine?
The FDA product code for Durex Condom with Benzocaine 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.