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FDA 510(k)

LifeStyles NRL Textured Condom

K-Number: K232279 · 2023-10-05

Decision Date2023-10-05
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LifeStyles NRL Textured Condom is a medical device manufactured by Suretex Limited. It received FDA 510(k) clearance on 2023-10-05 under approval number K232279. 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 LifeStyles NRL Textured Condom?

LifeStyles NRL Textured Condom is a medical device that received FDA 510(k) clearance on 2023-10-05. It is manufactured by Suretex Limited. The 510(k) number is K232279.

When was LifeStyles NRL Textured Condom approved by the FDA?

LifeStyles NRL Textured Condom received FDA 510(k) clearance on 2023-10-05, under approval number K232279.

What company makes LifeStyles NRL Textured Condom?

LifeStyles NRL Textured Condom is manufactured by Suretex Limited.

What is the FDA product code for LifeStyles NRL Textured Condom?

The FDA product code for LifeStyles NRL Textured Condom is HIS.

Other Devices by Suretex Limited

Related Devices (Code: HIS)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.