Device Type ID | 5269 |
Device Name | Apron, Leaded |
Regulation Description | Personnel Protective Shield. |
Regulation Medical Specialty | Radiology |
Review Panel | Radiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 892.6500 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | EAJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5269 |
Device | Apron, Leaded |
Product Code | EAJ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Personnel Protective Shield. |
CFR Regulation Number | 892.6500 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Contour Fabricators Inc | II | Oct-13-2016 |