Clearance Summary
MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2 received FDA 510(k) clearance under submission number K945238, sponsored by F. Walter Hanel GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1994-12-15.
- Submission: K945238
- Applicant / Sponsor: F. Walter Hanel GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1994-12-15
Classification & Regulation
This clearance is catalogued under FDA product code IWQ and 21 CFR 892.6500, within the Radiology review panel as a Class I device.