Durex Penck III Regular
K-Number: K222068 · 2022-10-12
ApplicantRb Health (Us), LLC
Decision Date2022-10-12
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Durex Penck III Regular is a medical device manufactured by Rb Health (Us), LLC. It received FDA 510(k) clearance on 2022-10-12 under approval number K222068. 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 Penck III Regular?
Durex Penck III Regular is a medical device that received FDA 510(k) clearance on 2022-10-12. It is manufactured by Rb Health (Us), LLC. The 510(k) number is K222068.
When was Durex Penck III Regular approved by the FDA?
Durex Penck III Regular received FDA 510(k) clearance on 2022-10-12, under approval number K222068.
What company makes Durex Penck III Regular?
Durex Penck III Regular is manufactured by Rb Health (Us), LLC.
What is the FDA product code for Durex Penck III Regular?
The FDA product code for Durex Penck III Regular 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.