K842763 is an FDA 510(k) clearance for the UNSCENTED MENSTRUAL PAD. This device is classified as a Pad, Menstrual, Unscented (Class I - General Controls, product code HHD).
Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1984, 25 days after receiving the submission on July 16, 1984.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5435. 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..
| 510(k) Number | K842763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1984 |
| Decision Date | August 10, 1984 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| 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. |