K945238 is an FDA 510(k) clearance for the MAVIG LOWER BODY PROTECTION SYSTEMS, ASSEMBLY MODELS 6265, 6266, 6267, 6268, 6269/0, 629/1, AND 6269/2. This device is classified as a Curtain, Protective, Radiographic (Class I - General Controls, product code IWQ).
Submitted by F. Walter Hanel GmbH (North Attleboro, US). The FDA issued a Cleared decision on December 15, 1994, 49 days after receiving the submission on October 27, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.6500.
| 510(k) Number | K945238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1994 |
| Decision Date | December 15, 1994 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IWQ — Curtain, Protective, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.6500 |