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 |