Tampon, Petal Soft Plastic Appli., Deodorant Super
by Tambrands Inc. 510(k)
Active
510(k) K896115
Overview
This device is a scented, deodorized menstrual tampon designed for internal use. It features a plastic applicator to facilitate insertion.
The device is classified as a class 2 medical device under regulation number 884.5460. It has received FDA 510(k) clearance under K896115.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896115 | Date13 Dec 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HIL
- FDA applicant
- Tambrands, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5460
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent