The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kotex Overnite.
| Device ID | K860587 |
| 510k Number | K860587 |
| Device Name: | KOTEX OVERNITE |
| Classification | Pad, Menstrual, Unscented |
| Applicant | KIMBERLY-CLARK CORP. 2100 WINCHESTER RD. P.O. BOX 2001 Neenah, WI 54957 -2001 |
| Contact | Bonnie B Wan |
| Correspondent | Bonnie B Wan KIMBERLY-CLARK CORP. 2100 WINCHESTER RD. P.O. BOX 2001 Neenah, WI 54957 -2001 |
| Product Code | HHD |
| CFR Regulation Number | 884.5435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-19 |
| Decision Date | 1986-03-13 |