The following data is part of a premarket notification filed by Procter & Gamble Co. with the FDA for Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl Unscented Tampons, Ultra.
| Device ID | K091281 |
| 510k Number | K091281 |
| Device Name: | TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | PROCTER & GAMBLE CO. 6110 CENTER HILL AVE. Cincinnati, OH 45224 |
| Contact | Kimberly A Nemeth |
| Correspondent | Kimberly A Nemeth PROCTER & GAMBLE CO. 6110 CENTER HILL AVE. Cincinnati, OH 45224 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-01 |
| Decision Date | 2010-06-01 |
| Summary: | summary |