Submission Details
| 510(k) Number | K131543 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 29, 2013 |
| Decision Date | June 20, 2013 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Special
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
Jun 2013
Decision
22d
Days
Class 2
Risk
About This 510(k) Submission
K131543 is an FDA 510(k) clearance for the TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on June 20, 2013, 22 days after receiving the submission on May 29, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.
Device Classification
| Product Code | HEB — Tampon, Menstrual, Unscented |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5470 |
| Definition | An Unscented 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. |
Manufacturer
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