The following data is part of a premarket notification filed by Jiangyin Caina Technology Co., Ltd. with the FDA for Disposable Insulin Syringe.
| Device ID | K151949 |
| 510k Number | K151949 |
| Device Name: | Disposable Insulin Syringe |
| Classification | Syringe, Piston |
| Applicant | JIANGYIN CAINA TECHNOLOGY CO., LTD. NO.2, TAIFU ROAD, HUASHI TOWN, JIANGYIN Jiangsu, CN 214421 |
| Contact | Jun Lu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-07-15 |
| Decision Date | 2015-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479231700 | K151949 | 000 |
| 20612479187881 | K151949 | 000 |
| 20612479187829 | K151949 | 000 |
| 20612479187768 | K151949 | 000 |
| 20612479187737 | K151949 | 000 |
| 20612479187676 | K151949 | 000 |
| 20612479187645 | K151949 | 000 |
| 40612479231823 | K151949 | 000 |
| 40612479231786 | K151949 | 000 |
| 40612479231748 | K151949 | 000 |
| 20192253064329 | K151949 | 000 |
| 20192253064312 | K151949 | 000 |
| 20612479187911 | K151949 | 000 |
| 20612479187942 | K151949 | 000 |
| 30193489008658 | K151949 | 000 |
| 30888277327447 | K151949 | 000 |
| 40888277327444 | K151949 | 000 |
| 20193489008637 | K151949 | 000 |
| 20193489008644 | K151949 | 000 |
| 20850044799538 | K151949 | 000 |
| 50192253035351 | K151949 | 000 |
| 16971564469682 | K151949 | 000 |
| 16971564467831 | K151949 | 000 |
| 30612479187864 | K151949 | 000 |
| 30612479187802 | K151949 | 000 |
| 20192253064305 | K151949 | 000 |