K852985 is an FDA 510(k) clearance for the UNSCENTED ALWAYS PANTILINERS. 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 August 29, 1985, 45 days after receiving the submission on July 15, 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 | K852985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1985 |
| Decision Date | August 29, 1985 |
| Days to Decision | 45 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. |