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 | K172118 |
| 510k Number | K172118 |
| Device Name: | U By Kotex Click Unscented Menstrual Tampons |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Kimberly-Clark Corporation 2100 Winchester Road Neenah, WI 54956 |
| Contact | Charnelle Thomas |
| Correspondent | Lori J. Barr Kimberly-Clark Corp. 2001 Marathon Ave. Neenah, WI 54956 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-13 |
| Decision Date | 2017-10-11 |