The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Tampax Ultrafit Panty Shields.
| Device ID | K884950 |
| 510k Number | K884950 |
| Device Name: | TAMPAX ULTRAFIT PANTY SHIELDS |
| Classification | Pad, Menstrual, Unscented |
| Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Contact | Davis, Phd |
| Correspondent | Davis, Phd TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Product Code | HHD |
| CFR Regulation Number | 884.5435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-25 |
| Decision Date | 1989-01-10 |