Device Type ID | 5254 |
Device Name | Cone, Radiographic, Lead-lined |
Regulation Description | Lead-lined Position Indicator. |
Regulation Medical Specialty | Dental |
Review Panel | Radiology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 872.1850 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | EAH |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5254 |
Device | Cone, Radiographic, Lead-lined |
Product Code | EAH |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Lead-lined Position Indicator. |
CFR Regulation Number | 872.1850 [🔎] |