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FDA 510(k)

PLAYTEX DIGITAL TAMPON

K-Number: K811385 · 1981-08-07

ApplicantPlaytex, Inc.
Decision Date1981-08-07
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PLAYTEX DIGITAL TAMPON is the device name listed in this FDA 510(k) record. The listed applicant is Playtex, Inc.. It received FDA 510(k) clearance on 1981-08-07 under 510(k) number K811385. 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 PLAYTEX DIGITAL TAMPON?

PLAYTEX DIGITAL TAMPON is a medical device that received FDA 510(k) clearance on 1981-08-07. The listed applicant is Playtex, Inc.. The 510(k) number is K811385.

When did PLAYTEX DIGITAL TAMPON receive FDA 510(k) clearance?

PLAYTEX DIGITAL TAMPON received FDA 510(k) clearance on 1981-08-07, under 510(k) number K811385.

Who is the listed applicant for PLAYTEX DIGITAL TAMPON?

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

What is the FDA product code for PLAYTEX DIGITAL TAMPON?

The FDA product code for PLAYTEX DIGITAL TAMPON is HEB.

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Other records listing Playtex, 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.

K120245PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONSK980478PLAYTEX TAMPONS #03498K971174PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONSK944064PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894K941044PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194K942418PLAYTEX TAMPONS MODEL 13794

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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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