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FDA 510(k)

REGULAR PETAL SOFT PLASTIC APPLICATOR

K-Number: K842619 · 1984-07-26

ApplicantTambrands, Inc.
Decision Date1984-07-26
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

REGULAR PETAL SOFT PLASTIC APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Tambrands, Inc.. It received FDA 510(k) clearance on 1984-07-26 under 510(k) number K842619. 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 REGULAR PETAL SOFT PLASTIC APPLICATOR?

REGULAR PETAL SOFT PLASTIC APPLICATOR is a medical device that received FDA 510(k) clearance on 1984-07-26. The listed applicant is Tambrands, Inc.. The 510(k) number is K842619.

When did REGULAR PETAL SOFT PLASTIC APPLICATOR receive FDA 510(k) clearance?

REGULAR PETAL SOFT PLASTIC APPLICATOR received FDA 510(k) clearance on 1984-07-26, under 510(k) number K842619.

Who is the listed applicant for REGULAR PETAL SOFT PLASTIC APPLICATOR?

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

What is the FDA product code for REGULAR PETAL SOFT PLASTIC APPLICATOR?

The FDA product code for REGULAR PETAL SOFT PLASTIC APPLICATOR is HEB.

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Other records listing Tambrands, 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.

K962476UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATORK960341TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUSK952344SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUSK944834UNSCENTED MENSTRUAL TAMPONSK923932TAMPAX TAMPONS, SUPER ABSORBENCYK924303TAMPAX TAMPON, REGULAR ABSORBENCY

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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

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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