The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Modification To: Horizon 9000ws.
| Device ID | K032997 |
| 510k Number | K032997 |
| Device Name: | MODIFICATION TO: HORIZON 9000WS |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | MENNEN MEDICAL LTD. 4 HAYARDEN ST. Yavne, IL 81228 |
| Contact | Erez Nimrod |
| Correspondent | Erez Nimrod MENNEN MEDICAL LTD. 4 HAYARDEN ST. Yavne, IL 81228 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-25 |
| Decision Date | 2003-10-15 |
| Summary: | summary |