The following data is part of a premarket notification filed by Playtex Manufacturing, Inc. with the FDA for Playtex Stella Tampons.
| Device ID | K180167 |
| 510k Number | K180167 |
| Device Name: | Playtex Stella Tampons |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Playtex Manufacturing, Inc. 804 Walker Road Dover, DE 19904 |
| Contact | Ludjane Fiorillo |
| Correspondent | Danielle Vitale Edgewell Personal Care 75 Commerce Drive Allendale, NJ 07401 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-05-30 |
| Summary: | summary |