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FDA 510(k)

FEMTEX 100% COTTON TAMPONS

K-Number: K971228 · 1997-04-09

ApplicantRegu-Tech Assoc., Inc.
Decision Date1997-04-09
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMTEX 100% COTTON TAMPONS is the device name listed in this FDA 510(k) record. The listed applicant is Regu-Tech Assoc., Inc.. It received FDA 510(k) clearance on 1997-04-09 under 510(k) number K971228. 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 100% COTTON TAMPONS?

FEMTEX 100% COTTON TAMPONS is a medical device that received FDA 510(k) clearance on 1997-04-09. The listed applicant is Regu-Tech Assoc., Inc.. The 510(k) number is K971228.

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

FEMTEX 100% COTTON TAMPONS received FDA 510(k) clearance on 1997-04-09, under 510(k) number K971228.

Who is the listed applicant for FEMTEX 100% COTTON TAMPONS?

The FDA 510(k) record lists Regu-Tech Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for FEMTEX 100% COTTON TAMPONS is HEB.

Related Clinical Trials

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Other records listing Regu-Tech Assoc., 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.

K970232FEMTEX 100% COTTON DENTLE TOUCH TAMPONSK963912TYCO BABY SESAME STREET SOFT TEETHER

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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