The following data is part of a premarket notification filed by F. Walter Hanel Gmbh with the FDA for Hanel Mavig Monitor Suspension System.
| Device ID | K954945 |
| 510k Number | K954945 |
| Device Name: | HANEL MAVIG MONITOR SUSPENSION SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | F. WALTER HANEL GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Mary M Mcnamara |
| Correspondent | Mary M Mcnamara F. WALTER HANEL GMBH 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-30 |
| Decision Date | 1996-01-29 |