Device Type ID | 5473 |
Device Name | Dressing, Compression |
Regulation Description | Elastic Bandage. |
Regulation Medical Specialty | General Hospital |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 880.5075 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | MHW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5473 |
Device | Dressing, Compression |
Product Code | MHW |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Elastic Bandage. |
CFR Regulation Number | 880.5075 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Amd Ritmed | II | Mar-25-2016 |