The following data is part of a premarket notification filed by F. Walter Hanel Gmbh with the FDA for Mavig Lower Body Protection Systems, Assembly Models 6265, 6266, 6267, 6268, 6269/0, 629/1, And 6269/2.
| Device ID | K945238 |
| 510k Number | K945238 |
| Device Name: | MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2 |
| Classification | Curtain, Protective, Radiographic |
| 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 | IWQ |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-27 |
| Decision Date | 1994-12-15 |