The following data is part of a premarket notification filed by Organic Essentials with the FDA for Organic Essentials, Organic Cotton Tampon.
| Device ID | K983478 |
| 510k Number | K983478 |
| Device Name: | ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | ORGANIC ESSENTIALS 822 BALDRIDGE ST. O'donnell, TX 79351 |
| Contact | La Rhea Pepper |
| Correspondent | La Rhea Pepper ORGANIC ESSENTIALS 822 BALDRIDGE ST. O'donnell, TX 79351 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-02 |
| Decision Date | 1998-11-09 |