Unscented W long plastic and cardboard applicator tampons
K-Number: K191666 · 2019-12-20
ApplicantOntex Bvba
Decision Date2019-12-20
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Unscented W long plastic and cardboard applicator tampons is a medical device manufactured by Ontex Bvba. It received FDA 510(k) clearance on 2019-12-20 under approval number K191666. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Unscented W long plastic and cardboard applicator tampons?
Unscented W long plastic and cardboard applicator tampons is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Ontex Bvba. The 510(k) number is K191666.
When was Unscented W long plastic and cardboard applicator tampons approved by the FDA?
Unscented W long plastic and cardboard applicator tampons received FDA 510(k) clearance on 2019-12-20, under approval number K191666.
What company makes Unscented W long plastic and cardboard applicator tampons?
Unscented W long plastic and cardboard applicator tampons is manufactured by Ontex Bvba.
What is the FDA product code for Unscented W long plastic and cardboard applicator tampons?
The FDA product code for Unscented W long plastic and cardboard applicator tampons is HEB.
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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.