K111684 is an FDA 510(k) clearance for the PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex Manufacturing, Inc. (Allendale, US). The FDA issued a Cleared decision on February 3, 2012, 233 days after receiving the submission on June 15, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.
| 510(k) Number | K111684 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 15, 2011 |
| Decision Date | February 03, 2012 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| 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. |