The following data is part of a premarket notification filed by Playtex, Inc. with the FDA for Playtex Gentle Glide Scented Tampons And Playtex Gentle Glide Unscented Tampons.
| Device ID | K120245 |
| 510k Number | K120245 |
| Device Name: | PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PLAYTEX, INC. 75 COMMERCE DRIVE Allendale, NJ 07401 |
| Contact | Pushpa Rao |
| Correspondent | Pushpa Rao PLAYTEX, INC. 75 COMMERCE DRIVE Allendale, NJ 07401 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-27 |
| Decision Date | 2012-06-21 |
| Summary: | summary |