The following data is part of a premarket notification filed by The Procter & Gamble Company with the FDA for Tampax(r) V Plastic Applicator Tampons, Unscented.
| Device ID | K113699 |
| 510k Number | K113699 |
| Device Name: | TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | THE PROCTER & GAMBLE COMPANY 6110 CANTER HILL AVENUE Cincinnati, OH 45224 |
| Contact | Kathleen Blieszner |
| Correspondent | Kathleen Blieszner THE PROCTER & GAMBLE COMPANY 6110 CANTER HILL AVENUE 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 | 2011-12-16 |
| Decision Date | 2012-01-12 |
| Summary: | summary |