The following data is part of a premarket notification filed by F. Walter Hanel Gmbh with the FDA for Mavig Angio Shield Models 6290 & 6272.
Device ID | K934206 |
510k Number | K934206 |
Device Name: | MAVIG ANGIO SHIELD MODELS 6290 & 6272 |
Classification | Shield, Protective, Personnel |
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 | KPY |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-30 |
Decision Date | 1993-10-07 |