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 |