The following data is part of a premarket notification filed by Playtex, Inc. with the FDA for Playtex Cotton Digital Tampon.
| Device ID | K811388 |
| 510k Number | K811388 |
| Device Name: | PLAYTEX COTTON DIGITAL TAMPON |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | PLAYTEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-18 |
| Decision Date | 1981-08-07 |