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FDA 510(k)

FEMTEX GENTLE TOUCH TAMPONS

K-Number: K963034 · 1996-11-01

ApplicantFirst Quality Hygienic, Inc.
Decision Date1996-11-01
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMTEX GENTLE TOUCH TAMPONS is the device name listed in this FDA 510(k) record. The listed applicant is First Quality Hygienic, Inc.. It received FDA 510(k) clearance on 1996-11-01 under 510(k) number K963034. 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 FEMTEX GENTLE TOUCH TAMPONS?

FEMTEX GENTLE TOUCH TAMPONS is a medical device that received FDA 510(k) clearance on 1996-11-01. The listed applicant is First Quality Hygienic, Inc.. The 510(k) number is K963034.

When did FEMTEX GENTLE TOUCH TAMPONS receive FDA 510(k) clearance?

FEMTEX GENTLE TOUCH TAMPONS received FDA 510(k) clearance on 1996-11-01, under 510(k) number K963034.

Who is the listed applicant for FEMTEX GENTLE TOUCH TAMPONS?

The FDA 510(k) record lists First Quality Hygienic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMTEX GENTLE TOUCH TAMPONS?

The FDA product code for FEMTEX GENTLE TOUCH TAMPONS is HEB.

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Other records listing First Quality Hygienic, Inc. 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.

K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super PlK051446FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONSK050660FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONSK050067FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSK032173FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONSK031067FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS

View all 10 devices →

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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