The following data is part of a premarket notification filed by Playtex, Inc. with the FDA for Playtex Non & Deodorant Tampons + Private Label.
Device ID | K874509 |
510k Number | K874509 |
Device Name: | PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL |
Classification | Tampon, Menstrual, Scented, Deodorized |
Applicant | PLAYTEX, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07653 |
Contact | Butensky, Phd |
Correspondent | Butensky, Phd PLAYTEX, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07653 |
Product Code | HIL |
CFR Regulation Number | 884.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-02 |
Decision Date | 1988-01-07 |