The following data is part of a premarket notification filed by Procter & Gamble Co. with the FDA for Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (unscented And Scented).
| Device ID | K051290 |
| 510k Number | K051290 |
| Device Name: | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED) |
| Classification | Tampon, Menstrual, Unscented |
| 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 | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-18 |
| Decision Date | 2005-12-27 |
| Summary: | summary |