K850955 is an FDA 510(k) clearance for the ALWAYS MAXIPADS - UNSCENTED. This device is classified as a Pad, Menstrual, Unscented (Class I - General Controls, product code HHD).
Submitted by Procter & Gamble Mfg. Co. (Cincinnati, US). The FDA issued a Cleared decision on May 14, 1985, 67 days after receiving the submission on March 8, 1985.
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 | K850955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1985 |
| Decision Date | May 14, 1985 |
| Days to Decision | 67 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. |