The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for U By Kotex Sleek Unscented Menstrual Tampons.
| Device ID | K112635 |
| 510k Number | K112635 |
| Device Name: | U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Contact | Swarna Mukund |
| Correspondent | Swarna Mukund KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-09 |
| Decision Date | 2011-10-07 |
| Summary: | summary |