One Touch Spiral Condom
K-Number: K210294 · 2021-09-23
Decision Date2021-09-23
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
One Touch Spiral Condom is a medical device manufactured by Thai Nippon Rubber Industry Public Company Limited.. It received FDA 510(k) clearance on 2021-09-23 under approval number K210294. 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 One Touch Spiral Condom?
One Touch Spiral Condom is a medical device that received FDA 510(k) clearance on 2021-09-23. It is manufactured by Thai Nippon Rubber Industry Public Company Limited.. The 510(k) number is K210294.
When was One Touch Spiral Condom approved by the FDA?
One Touch Spiral Condom received FDA 510(k) clearance on 2021-09-23, under approval number K210294.
What company makes One Touch Spiral Condom?
One Touch Spiral Condom is manufactured by Thai Nippon Rubber Industry Public Company Limited..
What is the FDA product code for One Touch Spiral Condom?
The FDA product code for One Touch Spiral Condom is HIS.
Other Devices by Thai Nippon Rubber Industry Public Company Limited.
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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.