| Device Type ID | 5719 |
| Device Name | Degreaser, Skin, Surgical |
| 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 | KOY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5719 |
| Device | Degreaser, Skin, Surgical |
| Product Code | KOY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Skin Degreaser Or Adhesive Tape Solvent. |
| CFR Regulation Number | 878.4730 [🔎] |
| Device Problems | |
|---|---|
Improper Chemical Reaction | 1 |
Product Quality Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Loss Of Or Failure To Bond | 1 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 1 |
| Total Device Problems | 5 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Covidien LLC | II | Mar-21-2016 |