The following data is part of a premarket notification filed by Procter & Gamble Co. with the FDA for Tampax Pearl Scented And Unscented Tampons - Junior, Regular, Super & Super Plus.
| Device ID | K011996 |
| 510k Number | K011996 |
| Device Name: | TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PROCTER & GAMBLE CO. 6110 CENTER HILL AVE. Cincinnati, OH 45224 |
| Contact | Mark M Anderson |
| Correspondent | Mark M Anderson PROCTER & GAMBLE CO. 6110 CENTER HILL AVE. Cincinnati, OH 45224 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-27 |
| Decision Date | 2001-09-19 |
| Summary: | summary |