| Device Type ID | 5718 |
| Device Name | Solvent, Adhesive Tape |
| Regulation Description | Surgical Skin Degreaser Or Adhesive Tape Solvent. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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 | 878.4730 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KOX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5718 |
| Device | Solvent, Adhesive Tape |
| Product Code | KOX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Skin Degreaser Or Adhesive Tape Solvent. |
| CFR Regulation Number | 878.4730 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Delivered As Unsterile Product | 1 |
Increased Sensitivity | 1 |
Patient-Device Incompatibility | 1 |
Device Operates Differently Than Expected | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Improper Chemical Reaction | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
| Total Device Problems | 11 |