The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for U By Kotex Click* Unscented Tampons, Model Absorbency: Regular, Super And Super Plus.
| Device ID | K091749 |
| 510k Number | K091749 |
| Device Name: | U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Cheryl Sanzare |
| Correspondent | Cheryl Sanzare KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-12-23 |
| Summary: | summary |