The following data is part of a premarket notification filed by Kimberly-clark Corporation with the FDA for U By Kotex Click Unscented Menstrual Tampons.
| Device ID | K113036 |
| 510k Number | K113036 |
| Device Name: | U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | KIMBERLY-CLARK CORPORATION 2001 MARATHON AVE Neeah, WI 54956 |
| Contact | Lori Barr |
| Correspondent | Lori Barr KIMBERLY-CLARK CORPORATION 2001 MARATHON AVE Neeah, 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 | 2011-10-12 |
| Decision Date | 2011-11-02 |
| Summary: | summary |