45 Micron Polyisoprene Condom
K-Number: K231908 · 2023-10-27
ApplicantSuretex Limited
Decision Date2023-10-27
Product CodeMOL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
45 Micron Polyisoprene Condom is a medical device manufactured by Suretex Limited. It received FDA 510(k) clearance on 2023-10-27 under approval number K231908. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 45 Micron Polyisoprene Condom?
45 Micron Polyisoprene Condom is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Suretex Limited. The 510(k) number is K231908.
When was 45 Micron Polyisoprene Condom approved by the FDA?
45 Micron Polyisoprene Condom received FDA 510(k) clearance on 2023-10-27, under approval number K231908.
What company makes 45 Micron Polyisoprene Condom?
45 Micron Polyisoprene Condom is manufactured by Suretex Limited.
What is the FDA product code for 45 Micron Polyisoprene Condom?
The FDA product code for 45 Micron Polyisoprene Condom is MOL.
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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.