The following data is part of a premarket notification filed by Jiangsu Micsafe Medical Technology Co., Ltd with the FDA for Insulin Syringe, Insulin Syringe With Safety Retractable.
| Device ID | K202570 |
| 510k Number | K202570 |
| Device Name: | Insulin Syringe, Insulin Syringe With Safety Retractable |
| Classification | Syringe, Antistick |
| Applicant | Jiangsu Micsafe Medical Technology Co., Ltd Xituan Industrial Park, Dafeng District Yancheng, CN 224125 |
| Contact | Tony Yang |
| Correspondent | Tony Yang Jiangsu Micsafe Medical Technology Co., Ltd Xituan Industrial Park, Dafeng District Yancheng, CN 224125 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-04 |
| Decision Date | 2021-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10386120012855 | K202570 | 000 |
| 10386120012947 | K202570 | 000 |
| 10386120012848 | K202570 | 000 |
| 10386120012824 | K202570 | 000 |
| 10386120012817 | K202570 | 000 |
| 10386120012794 | K202570 | 000 |
| 10386120012787 | K202570 | 000 |
| 16971911296565 | K202570 | 000 |
| 16971911296558 | K202570 | 000 |
| 10386120012954 | K202570 | 000 |
| 10386120012961 | K202570 | 000 |
| 10386120012831 | K202570 | 000 |
| 10386120012800 | K202570 | 000 |
| 10386120012770 | K202570 | 000 |
| 10386120012763 | K202570 | 000 |
| 10386120012756 | K202570 | 000 |
| 10386120012992 | K202570 | 000 |
| 10386120012985 | K202570 | 000 |
| 10386120012978 | K202570 | 000 |
| 16971911296527 | K202570 | 000 |