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FDA 510(k)

ONTEX TAMPON (UNSCENTED)

K-Number: K090819 · 2009-12-23

ApplicantOntex International NV
Decision Date2009-12-23
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ONTEX TAMPON (UNSCENTED) is the device name listed in this FDA 510(k) record. The listed applicant is Ontex International NV. It received FDA 510(k) clearance on 2009-12-23 under 510(k) number K090819. 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 ONTEX TAMPON (UNSCENTED)?

ONTEX TAMPON (UNSCENTED) is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Ontex International NV. The 510(k) number is K090819.

When did ONTEX TAMPON (UNSCENTED) receive FDA 510(k) clearance?

ONTEX TAMPON (UNSCENTED) received FDA 510(k) clearance on 2009-12-23, under 510(k) number K090819.

Who is the listed applicant for ONTEX TAMPON (UNSCENTED)?

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

What is the FDA product code for ONTEX TAMPON (UNSCENTED)?

The FDA product code for ONTEX TAMPON (UNSCENTED) is HEB.

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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.

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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.

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