The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Super Tampax Tampons.
Device ID | K844936 |
510k Number | K844936 |
Device Name: | SUPER TAMPAX TAMPONS |
Classification | Tampon, Menstrual, Unscented |
Applicant | TAMBRANDS, INC. 2020 K ST. NW Washington, DC 20006 |
Contact | John Fellman |
Correspondent | John Fellman TAMBRANDS, INC. 2020 K ST. NW Washington, DC 20006 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-19 |
Decision Date | 1985-02-07 |