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 (retractable).
| Device ID | K220183 |
| 510k Number | K220183 |
| Device Name: | Sterile Safety Syringes For Single Use (Retractable) |
| Classification | Syringe, Antistick |
| Applicant | Shanghai Kindly Enterprise Development Group Co., Ltd No. 658 Gaochao Road Shanghai, CN 201803 |
| Contact | Liu Hualong |
| Correspondent | Ryan Li Shanghai Mind-link Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai, CN 200040 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-24 |
| Decision Date | 2022-07-21 |