Durex Penck Standard, Durex Penck XL
K-Number: K200672 · 2020-11-06
ApplicantRb Health (Us), LLC
Decision Date2020-11-06
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Durex Penck Standard, Durex Penck XL is a medical device manufactured by Rb Health (Us), LLC. It received FDA 510(k) clearance on 2020-11-06 under approval number K200672. 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 Standard, Durex Penck XL?
Durex Penck Standard, Durex Penck XL is a medical device that received FDA 510(k) clearance on 2020-11-06. It is manufactured by Rb Health (Us), LLC. The 510(k) number is K200672.
When was Durex Penck Standard, Durex Penck XL approved by the FDA?
Durex Penck Standard, Durex Penck XL received FDA 510(k) clearance on 2020-11-06, under approval number K200672.
What company makes Durex Penck Standard, Durex Penck XL?
Durex Penck Standard, Durex Penck XL is manufactured by Rb Health (Us), LLC.
What is the FDA product code for Durex Penck Standard, Durex Penck XL?
The FDA product code for Durex Penck Standard, Durex Penck XL 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.