Device Type ID | 4594 |
Device Name | Instrument, Cast Application/removal, Manual |
Regulation Description | Manual Cast Application And Removal Instrument. |
Regulation Medical Specialty | Orthopedic |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 888.5980 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | LGG |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4594 |
Device | Instrument, Cast Application/removal, Manual |
Product Code | LGG |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Manual Cast Application And Removal Instrument. |
CFR Regulation Number | 888.5980 [🔎] |