The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Original Regular Tampax Tampons.
| Device ID | K844935 |
| 510k Number | K844935 |
| Device Name: | ORIGINAL REGULAR 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 |