The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Satin Touch Deodorant Tampon Junior, Regular, Super, Super Plus.
Device ID | K952344 |
510k Number | K952344 |
Device Name: | SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS |
Classification | Tampon, Menstrual, Scented, Deodorized |
Applicant | TAMBRANDS, INC. 777 WESTCHESTER AVE. White Plains, NY 10604 |
Contact | Jerome B Eainick |
Correspondent | Jerome B Eainick TAMBRANDS, INC. 777 WESTCHESTER AVE. White Plains, NY 10604 |
Product Code | HIL |
CFR Regulation Number | 884.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-19 |
Decision Date | 1995-07-28 |