The following data is part of a premarket notification filed by Procter & Gamble Co. with the FDA for Tampax(r) L Plastic Tampons, Unscented.
| Device ID | K131543 |
| 510k Number | K131543 |
| Device Name: | TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | PROCTER & GAMBLE CO. 6110 CENTER HILL AVE. Cincinnati, OH 45224 |
| Contact | Kathleen Blieszner |
| Correspondent | Kathleen Blieszner PROCTER & GAMBLE CO. 6110 CENTER HILL AVE. Cincinnati, OH 45224 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-29 |
| Decision Date | 2013-06-20 |
| Summary: | summary |