The following data is part of a premarket notification filed by Shanghai Kindly Enterprise Development Group Co., Ltd with the FDA for Sterile Safety Syringes For Single Use.
| Device ID | K221416 |
| 510k Number | K221416 |
| Device Name: | Sterile Safety Syringes For Single Use |
| Classification | Syringe, Antistick |
| Applicant | Shanghai Kindly Enterprise Development Group Co., Ltd No. 658 Gaochao Road Shanghai, CN 201803 |
| Contact | Liu Hualong |
| Correspondent | Evan Hu Shanghai Mind-Link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai, CN 200040 |
| Product Code | MEG |
| Subsequent Product Code | FMF |
| Subsequent Product Code | FMI |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-16 |
| Decision Date | 2022-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26930197851803 | K221416 | 000 |
| 26930197851797 | K221416 | 000 |
| 06930197851786 | K221416 | 000 |
| 26930197851773 | K221416 | 000 |
| 26930197851759 | K221416 | 000 |
| 26930197851742 | K221416 | 000 |
| 26930197851735 | K221416 | 000 |
| 16930197851721 | K221416 | 000 |