The following data is part of a premarket notification filed by Shantou Wealy Medical Instrument Co.,ltd with the FDA for Disposable Automatically Retractable Insulin Safety Syringe.
| Device ID | K210216 |
| 510k Number | K210216 |
| Device Name: | Disposable Automatically Retractable Insulin Safety Syringe |
| Classification | Syringe, Antistick |
| Applicant | Shantou Wealy Medical Instrument CO.,Ltd North Jinhuan Road Shantou, CN 515064 |
| Contact | Yuhe Yang |
| Correspondent | Raymond Luo Shanghai SUNGO Management Consulting Company Limited. Room 1309, 1500# Century Avenue Shanghai, CN 200122 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-27 |
| Decision Date | 2022-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00369771003123 | K210216 | 000 |
| 10386120013012 | K210216 | 000 |
| 10386120013005 | K210216 | 000 |