K012629 is an FDA 510(k) clearance for the ALWAYS DUETS, 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 October 5, 2001, 53 days after receiving the submission on August 13, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.
| 510(k) Number | K012629 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 13, 2001 |
| Decision Date | October 05, 2001 |
| Days to Decision | 53 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. |