Device Type ID | 3017 |
Device Name | Support Gels |
Regulation Description | Support Gel. |
Regulation Medical Specialty | Immunology |
Review Panel | Immunology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 866.4900 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | JZR |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3017 |
Device | Support Gels |
Product Code | JZR |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Support Gel. |
CFR Regulation Number | 866.4900 [🔎] |