| Device Type ID | 5469 |
| Device Name | Bandage, Liquid |
| Regulation Description | Liquid 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) |
| CFR Regulation Number | 880.5090 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KMF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5469 |
| Device | Bandage, Liquid |
| Product Code | KMF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Liquid Bandage. |
| CFR Regulation Number | 880.5090 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
3M HEALTH CARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ADVANCED MEDICAL SOLUTIONS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KERICURE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHAL INDUSTRIES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fire | 14 |
Adverse Event Without Identified Device Or Use Problem | 13 |
Improper Or Incorrect Procedure Or Method | 9 |
Use Of Device Problem | 4 |
Insufficient Information | 4 |
Device Contamination With Chemical Or Other Material | 1 |
Inadequate Or Insufficient Training | 1 |
Device Operates Differently Than Expected | 1 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 48 |