The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Modification To Computerized Catheterization Laboratory - Horizon 9000 Ws.
| Device ID | K991775 |
| 510k Number | K991775 |
| Device Name: | MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot, IL 76100 |
| Contact | Kenneth Raichman |
| Correspondent | Kenneth Raichman MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot, IL 76100 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-25 |
| Decision Date | 1999-06-24 |
| Summary: | summary |