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FDA 510(k)

ONTEX AND OTHER PROPRIETARY NAMES

K-Number: K122603 · 2012-12-19

ApplicantOntex Bvba
Decision Date2012-12-19
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ONTEX AND OTHER PROPRIETARY NAMES is the device name listed in this FDA 510(k) record. The listed applicant is Ontex Bvba. It received FDA 510(k) clearance on 2012-12-19 under 510(k) number K122603. 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 AND OTHER PROPRIETARY NAMES?

ONTEX AND OTHER PROPRIETARY NAMES is a medical device that received FDA 510(k) clearance on 2012-12-19. The listed applicant is Ontex Bvba. The 510(k) number is K122603.

When did ONTEX AND OTHER PROPRIETARY NAMES receive FDA 510(k) clearance?

ONTEX AND OTHER PROPRIETARY NAMES received FDA 510(k) clearance on 2012-12-19, under 510(k) number K122603.

Who is the listed applicant for ONTEX AND OTHER PROPRIETARY NAMES?

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 ONTEX AND OTHER PROPRIETARY NAMES?

The FDA product code for ONTEX AND OTHER PROPRIETARY NAMES is HEB.

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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.

K191666Unscented W long plastic and cardboard applicator tamponsK162746Ontex and other proprietary names

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.

K252005Livi DeviceLiviwell, Inc.K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONSCotton High Tech S.L.K252613Unscented menstrual three-piece applicator tamponUnibeauty (Hubei) Technology Co., Ltd.K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K242105SABA TamponsEssity Higiene Y Salud Mexico. S.A. DE C.V.

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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