K913747 is an FDA 510(k) clearance for the STAYFREE(TM) MAXI-PAD, a Pad, Menstrual, Unscented (Class I — General Controls, product code HHD), submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on November 5, 1991, 76 days after receiving the submission on August 21, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.
| 510(k) Number | K913747 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1991 |
| Decision Date | November 05, 1991 |
| Days to Decision | 76 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. |