Shanghai Suokang Medical Implants Co., Ltd. · Class II · Cleared Jun 13, 2023
| K-number | K201153 |
| Device name | Tisuthes e-PTFE Surgical Patch |
| Applicant | Shanghai Suokang Medical Implants Co., Ltd. |
| Product code | OWR |
| Device class | Class II |
| Decision date | Jun 13, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 878.3300 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov