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FDA 510(k)

COTTONS 100% NATURAL COTTON TAMPONS

K-Number: K080733 · 2009-02-18

ApplicantCottons Pty, Ltd.
Decision Date2009-02-18
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COTTONS 100% NATURAL COTTON TAMPONS is the device name listed in this FDA 510(k) record. The listed applicant is Cottons Pty, Ltd.. It received FDA 510(k) clearance on 2009-02-18 under 510(k) number K080733. 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 COTTONS 100% NATURAL COTTON TAMPONS?

COTTONS 100% NATURAL COTTON TAMPONS is a medical device that received FDA 510(k) clearance on 2009-02-18. The listed applicant is Cottons Pty, Ltd.. The 510(k) number is K080733.

When did COTTONS 100% NATURAL COTTON TAMPONS receive FDA 510(k) clearance?

COTTONS 100% NATURAL COTTON TAMPONS received FDA 510(k) clearance on 2009-02-18, under 510(k) number K080733.

Who is the listed applicant for COTTONS 100% NATURAL COTTON TAMPONS?

The FDA 510(k) record lists Cottons Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COTTONS 100% NATURAL COTTON TAMPONS?

The FDA product code for COTTONS 100% NATURAL COTTON 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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