The following data is part of a premarket notification filed by Cottons Pty, Ltd with the FDA for Cottons 100% Natural Cotton Tampons.
| Device ID | K080733 |
| 510k Number | K080733 |
| Device Name: | COTTONS 100% NATURAL COTTON TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | COTTONS PTY, LTD 3817 SEVILLE RD. Denton, TX 76205 -8409 |
| Contact | Robert Seiple |
| Correspondent | Robert Seiple COTTONS PTY, LTD 3817 SEVILLE RD. Denton, TX 76205 -8409 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-14 |
| Decision Date | 2009-02-18 |
| Summary: | summary |