The following data is part of a premarket notification filed by Kimberly Clark Corporation with the FDA for U By Kotex Click Unscented Menstrul Tampons.
| Device ID | K103311 |
| 510k Number | K103311 |
| Device Name: | U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | KIMBERLY CLARK CORPORATION 2100 WINCHESTER ROAD Neenah, WI 54956 |
| Contact | Cheryl Sanzare |
| Correspondent | Cheryl Sanzare KIMBERLY CLARK CORPORATION 2100 WINCHESTER ROAD Neenah, WI 54956 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-10 |
| Decision Date | 2010-12-10 |
| Summary: | summary |