The following data is part of a premarket notification filed by Playtex, Inc. with the FDA for Playtex Slender Regular Tampons.
Device ID | K841154 |
510k Number | K841154 |
Device Name: | PLAYTEX SLENDER REGULAR TAMPONS |
Classification | Tampon, Menstrual, Scented, Deodorized |
Applicant | PLAYTEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HIL |
CFR Regulation Number | 884.5460 [🔎] |
Decision | Se - Postmarket Surveillance Required (SESP) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-19 |
Decision Date | 1984-03-19 |