K853000 is an FDA 510(k) clearance for the SCENTED ALWAYS PANTILINERS. This device is classified as a Pad, Menstrual, Scented, Scented-deodorized (Class II - Special Controls, product code HHL).
Submitted by Procter & Gamble Mfg. Co. (Cincinnati, US). The FDA issued a Cleared decision on September 6, 1985, 53 days after receiving the submission on July 15, 1985.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5425. Scented Or Scented-deodorized Menstrual Pads Used To Absorb Menstrual Or Other Vaginal Discharge, Including Those Intended As Intralabial Pads Or Reusable Menstrual Pads. These Are Made With Materials That Do Not Meet The Requirements For Class 1 Per 21 Cfr 884.5425(b)..
| 510(k) Number | K853000 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1985 |
| Decision Date | September 06, 1985 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHL — Pad, Menstrual, Scented, Scented-deodorized |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5425 |
| Definition | Scented Or Scented-deodorized Menstrual Pads Used To Absorb Menstrual Or Other Vaginal Discharge, Including Those Intended As Intralabial Pads Or Reusable Menstrual Pads. These Are Made With Materials That Do Not Meet The Requirements For Class 1 Per 21 Cfr 884.5425(b). |