The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Unscented Menstrual Tampons.
| Device ID | K944834 |
| 510k Number | K944834 |
| Device Name: | UNSCENTED MENSTRUAL TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TAMBRANDS, INC. 777 WESTCHESTER AVE. White Plains, NY 10604 |
| Contact | Jerome B Wainick |
| Correspondent | Jerome B Wainick TAMBRANDS, INC. 777 WESTCHESTER AVE. White Plains, NY 10604 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-30 |
| Decision Date | 1994-12-21 |