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FDA 510(k)

MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS

K-Number: K091084 · 2009-04-29

ApplicantCotton High Tech S.L.
Decision Date2009-04-29
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS is the device name listed in this FDA 510(k) record. The listed applicant is Cotton High Tech S.L.. It received FDA 510(k) clearance on 2009-04-29 under 510(k) number K091084. 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 MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS?

MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS is a medical device that received FDA 510(k) clearance on 2009-04-29. The listed applicant is Cotton High Tech S.L.. The 510(k) number is K091084.

When did MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS receive FDA 510(k) clearance?

MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS received FDA 510(k) clearance on 2009-04-29, under 510(k) number K091084.

Who is the listed applicant for MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS?

The FDA 510(k) record lists Cotton High Tech S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS?

The FDA product code for MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS is HEB.

Related Clinical Trials

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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Other records listing Cotton High Tech S.L. 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.

K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONSK220238Cohitech Cottonlock Tampons with Reusable ApplicatorK211775Cohitech Organic Cotton Non-Applicator Cottonlock TamponsK212479Cohitech Reusable Tampon ApplicatorK182813COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT

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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