The following data is part of a premarket notification filed by Playtex Manufacturing Inc. with the FDA for Playtex (scented And Unscented) Sport Fresh Balance Tampons.
| Device ID | K132819 |
| 510k Number | K132819 |
| Device Name: | PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PLAYTEX MANUFACTURING INC. 75 COMMERCE DR. Allendale, NJ 07401 |
| Contact | Pushpa Rao |
| Correspondent | Pushpa Rao PLAYTEX MANUFACTURING INC. 75 COMMERCE DR. Allendale, NJ 07401 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2013-10-09 |
| Summary: | summary |