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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ontex Bvba. It received FDA 510(k) clearance on 2019-12-20 under 510(k) 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. The listed applicant is Ontex Bvba. The 510(k) number is K191666.

When did Unscented W long plastic and cardboard applicator tampons receive FDA 510(k) clearance?

Unscented W long plastic and cardboard applicator tampons received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191666.

Who is the listed applicant for Unscented W long plastic and cardboard applicator tampons?

The FDA 510(k) record lists Ontex Bvba as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Ontex Bvba as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: HEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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