Device Type ID | 5466 |
Device Name | Strip, Adhesive, Closure, Skin |
Regulation Description | Medical Adhesive Tape And Adhesive Bandage. |
Regulation Medical Specialty | General Hospital |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
Submission Type | 510(k) |
CFR Regulation Number | 880.5240 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FPX |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5466 |
Device | Strip, Adhesive, Closure, Skin |
Product Code | FPX |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Medical Adhesive Tape And Adhesive Bandage. |
CFR Regulation Number | 880.5240 [🔎] |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Total Device Problems | 2 |