The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe.
| Device ID | K191490 |
| 510k Number | K191490 |
| Device Name: | Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe |
| Classification | Syringe, Antistick |
| Applicant | Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214425 |
| Contact | Xinyan Ruan |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-05 |
| Decision Date | 2019-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20612479256808 | K191490 | 000 |
| 20612479256778 | K191490 | 000 |
| 20612479256747 | K191490 | 000 |
| 40612479260885 | K191490 | 000 |
| 40612479260854 | K191490 | 000 |
| 40612479260823 | K191490 | 000 |