K953668 is an FDA 510(k) clearance for the UNSCENTED ULTRATHIN MAXI PAD. This device is classified as a Pad, Menstrual, Unscented (Class I - General Controls, product code HHD).
Submitted by Paragon Trade Brands, Inc. (Federal Way, US). The FDA issued a Cleared decision on November 1, 1995, 86 days after receiving the submission on August 7, 1995.
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 | K953668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1995 |
| Decision Date | November 01, 1995 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| 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. |