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FDA 510(k)

TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED

K-Number: K113699 · 2012-01-12

ApplicantThe Procter & Gamble Company
Decision Date2012-01-12
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED is the device name listed in this FDA 510(k) record. The listed applicant is The Procter & Gamble Company. It received FDA 510(k) clearance on 2012-01-12 under 510(k) number K113699. 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 TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED?

TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED is a medical device that received FDA 510(k) clearance on 2012-01-12. The listed applicant is The Procter & Gamble Company. The 510(k) number is K113699.

When did TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED receive FDA 510(k) clearance?

TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED received FDA 510(k) clearance on 2012-01-12, under 510(k) number K113699.

Who is the listed applicant for TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED?

The FDA 510(k) record lists The Procter & Gamble Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED?

The FDA product code for TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED 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

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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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