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Tampon, Playtex 2 Version B

by Intl. Playtex, Inc.

510(k) K760426

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760426 Date26 Aug 1976ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HIL
Device Class
Class II
Regulation
21 CFR Part 884.5460
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tampon, Playtex 2 Version B is a menstrual tampon, classified as a class 2 device. It is used in the field of obstetrics and gynecology. The device is scented and deodorized.

The Tampon, Playtex 2 Version B is supplied with FDA 510(k) clearance, with the decision description being Substantially Equivalent. The device has a product code of HIL and a regulation number of 884.5460, and is used in the medical specialty of obstetrics and gynecology.

Other devices from Playtex, Inc.

See all devices from Playtex, Inc. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Playtex 2 Version B Tampon used for?

    The Playtex 2 Version B Tampon is used in the field of obstetrics and gynecology as a menstrual tampon.

  • Is the Playtex 2 Version B Tampon scented?

    Yes, the Playtex 2 Version B Tampon is scented and deodorized.

  • What is the regulatory status of the Playtex 2 Version B Tampon?

    The Playtex 2 Version B Tampon has FDA 510(k) clearance with a decision description of Substantially Equivalent.