The following data is part of a premarket notification filed by Jiangyin Caina Technology Co., Ltd with the FDA for Disposable Infusion Needle, Safelock Disposable Infusion Needle.
| Device ID | K152323 |
| 510k Number | K152323 |
| Device Name: | Disposable Infusion Needle, Safelock Disposable Infusion Needle |
| Classification | Set, Administration, Intravascular |
| Applicant | JIANGYIN CAINA TECHNOLOGY CO., LTD NO. 2, TAIFU ROAD, HUASHI TOWN Jiangyin, CN 214421 |
| Contact | Jun Lu |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-17 |
| Decision Date | 2015-12-14 |
| Summary: | summary |