The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Tampax Closed-end Flushable Tampon, Orig. Regular.
| Device ID | K870359 |
| 510k Number | K870359 |
| Device Name: | TAMPAX CLOSED-END FLUSHABLE TAMPON, ORIG. REGULAR |
| Classification | Tampon, Menstrual, Unscented |
| 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 | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-29 |
| Decision Date | 1987-02-25 |