K811386 is an FDA 510(k) clearance for the PLAYTEX PROCESS MACHINERY CHANGE. This device is classified as a Tampon, Menstrual, Scented, Scented-deodorized (Class II - Special Controls, product code HIL).
Submitted by Playtex, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981, 53 days after receiving the submission on May 18, 1981.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5460. A Scented Or Scented-deodorized Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge..
| 510(k) Number | K811386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1981 |
| Decision Date | July 10, 1981 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HIL — Tampon, Menstrual, Scented, Scented-deodorized |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5460 |
| Definition | A Scented Or Scented-deodorized Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge. |