The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Tampax Ultrafit Panty Shields/dedorant-modificatio.
| Device ID | K891473 |
| 510k Number | K891473 |
| Device Name: | TAMPAX ULTRAFIT PANTY SHIELDS/DEDORANT-MODIFICATIO |
| Classification | Pad, Menstrual, Scented |
| Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Contact | Yale Gressel |
| Correspondent | Yale Gressel TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Product Code | HHL |
| CFR Regulation Number | 884.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-16 |
| Decision Date | 1989-06-07 |