The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Tampax Tampons, Various Sizes/types (modification).
| Device ID | K862353 |
| 510k Number | K862353 |
| Device Name: | TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION) |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Contact | Robert J Staab |
| Correspondent | Robert J Staab TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-20 |
| Decision Date | 1986-07-09 |