The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd with the FDA for Plastic Lor Syringe.
| Device ID | K201356 |
| 510k Number | K201356 |
| Device Name: | Plastic LOR Syringe |
| Classification | Anesthesia Conduction Kit |
| Applicant | Jiangsu Caina Medical Co., Ltd No.23,Huanxi Rd. Zhutang Town Jiangyin, CN 214415 |
| Contact | Jianwei Pan |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, CN 200120 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-21 |
| Decision Date | 2021-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20193489031796 | K201356 | 000 |
| 20193489031789 | K201356 | 000 |
| 20193489031772 | K201356 | 000 |
| 20193489031765 | K201356 | 000 |