K003843 is an FDA 510(k) clearance for the ENVIVE MINIFORMS, a Pad, Menstrual, Unscented (Class I — General Controls, product code HHD), submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on February 8, 2001, 58 days after receiving the submission on December 12, 2000. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.
| 510(k) Number | K003843 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 12, 2000 |
| Decision Date | February 08, 2001 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHD — Pad, Menstrual, Unscented |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 884.5435 |
| Definition | An Unscented Menstrual Pad Which Is Used To Absorb Menstrual Fluid Or Other Vaginal Discharge And Is Made Of Common Cellulosic And Synthetic Material With An Established Safety Profile. |