The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Tampax Compak, Compact Plastic Appli. Regu. Tampon.
| Device ID | K880023 |
| 510k Number | K880023 |
| Device Name: | TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Contact | Staab, Phd |
| Correspondent | Staab, Phd 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 | 1988-01-05 |
| Decision Date | 1988-03-02 |