The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Horizon Se.
| Device ID | K070254 |
| 510k Number | K070254 |
| Device Name: | HORIZON SE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MENNEN MEDICAL LTD. 4 HAYARDEN ST. P.O. BOX 102 REHOVOT Yavne, IL 76100 |
| Contact | Micha Oestereich |
| Correspondent | Micha Oestereich MENNEN MEDICAL LTD. 4 HAYARDEN ST. P.O. BOX 102 REHOVOT Yavne, IL 76100 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-26 |
| Decision Date | 2007-04-19 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HORIZON SE 78542645 3152907 Dead/Cancelled |
Mennen Medical Corp. 2005-01-05 |