The following data is part of a premarket notification filed by Procter & Gamble Co. with the FDA for Envive Miniforms.
| Device ID | K003843 |
| 510k Number | K003843 |
| Device Name: | ENVIVE MINIFORMS |
| Classification | Pad, Menstrual, Unscented |
| Applicant | PROCTER & GAMBLE CO. 6110 CENTER HILL AVE. Cincinnati, OH 45224 |
| Contact | Kathleen C Bliezner |
| Correspondent | Kathleen C Bliezner PROCTER & GAMBLE CO. 6110 CENTER HILL AVE. Cincinnati, OH 45224 |
| Product Code | HHD |
| CFR Regulation Number | 884.5435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-12 |
| Decision Date | 2001-02-08 |