Tampon, Playtex 2 Version B
510(k) K760426
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760426 | Date26 Aug 1976 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Questions
AI-generated answers, 1 Oct 2026
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.