HORIZON XVU
Computer, Diagnostic, Programmable
MENNEN MEDICAL LTD.
The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Horizon Xvu.
Pre-market Notification Details
| Device ID | K091165 |
| 510k Number | K091165 |
| Device Name: | HORIZON XVU |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot, IL 76100 |
| Contact | Ifat Oren |
| Correspondent | Ifat Oren MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot, 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 | 2009-04-22 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
Trademark Results [HORIZON XVU]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HORIZON XVU 77167416 3507106 Dead/Cancelled |
Mennen Medical Corp. 2007-04-27 |
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