Platex Tampons Model Number 07094

by Playtex Family Products, Inc.

510(k) K941196

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 26 Oct 2026

Documents

510(k) K941196↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK941196	Date19 Apr 1994Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K941196
FDA Product Code: HIL

Device Class: Class II
Regulation: 21 CFR Part 884.5460
Advisory Committee: Obstetrics/Gynecology
FDA Decision: SESE Substantially Equivalent

Other devices from Playtex Family Products, Inc.

Playtex Tampons #04994 Unscented & Scented

Class II
Playtex Flushable Tampons Regular, Super, Super +

Class II
Playtex Non-Deodorant and Deodorant Tampons

Class II
Playtex Non-Deodorant Tampons, Playtex Deodorant Tampons

Class II
Playtex Ultimates Tampons/Unscented and Scented

Class II
Scented or Scented Deodorized, Unscented Tampons

Class II

See all devices from Playtex Family Products, Inc. →