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FDA 510(k)

MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS

K-Number: K080775 · 2008-09-10

ApplicantTosama D.D.
Decision Date2008-09-10
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS is the device name listed in this FDA 510(k) record. The listed applicant is Tosama D.D.. It received FDA 510(k) clearance on 2008-09-10 under 510(k) number K080775. 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 PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS?

MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS is a medical device that received FDA 510(k) clearance on 2008-09-10. The listed applicant is Tosama D.D.. The 510(k) number is K080775.

When did MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS receive FDA 510(k) clearance?

MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS received FDA 510(k) clearance on 2008-09-10, under 510(k) number K080775.

Who is the listed applicant for MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS?

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

What is the FDA product code for MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS?

The FDA product code for MAXIM PLASTIC APPLICATOR & NON-APPLICATOR 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 Tosama D.D. 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.

K092054MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON

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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