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FDA 510(k)

U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS

K-Number: K112635 · 2011-10-07

ApplicantKimberly-Clark Corp.
Decision Date2011-10-07
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 2011-10-07 under 510(k) number K112635. 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 U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS?

U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS is a medical device that received FDA 510(k) clearance on 2011-10-07. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K112635.

When did U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS receive FDA 510(k) clearance?

U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS received FDA 510(k) clearance on 2011-10-07, under 510(k) number K112635.

Who is the listed applicant for U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS?

The FDA 510(k) record lists Kimberly-Clark Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS?

The FDA product code for U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS 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.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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