Decision Date2017-10-12
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
JUD custom fit condom is a medical device manufactured by Global Mailer Partners, LLC. It received FDA 510(k) clearance on 2017-10-12 under approval number K172414. 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 JUD custom fit condom?
JUD custom fit condom is a medical device that received FDA 510(k) clearance on 2017-10-12. It is manufactured by Global Mailer Partners, LLC. The 510(k) number is K172414.
When was JUD custom fit condom approved by the FDA?
JUD custom fit condom received FDA 510(k) clearance on 2017-10-12, under approval number K172414.
What company makes JUD custom fit condom?
JUD custom fit condom is manufactured by Global Mailer Partners, LLC.
What is the FDA product code for JUD custom fit condom?
The FDA product code for JUD custom fit condom is HIS.
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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.