The following data is part of a premarket notification filed by Jiangyin Caina Technology Co., Ltd with the FDA for Safety Disposable Insulin Syringe.
| Device ID | K150758 |
| 510k Number | K150758 |
| Device Name: | Safety Disposable Insulin Syringe |
| Classification | Syringe, Piston |
| 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 | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-23 |
| Decision Date | 2015-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784893921 | K150758 | 000 |
| 16971564467473 | K150758 | 000 |
| 00850005565666 | K150758 | 000 |
| 00850005565642 | K150758 | 000 |
| 30840330703681 | K150758 | 000 |
| 30840330703674 | K150758 | 000 |
| 30840330703667 | K150758 | 000 |
| 30840330703650 | K150758 | 000 |
| 30840330703643 | K150758 | 000 |
| 30840330703636 | K150758 | 000 |
| 30840330703629 | K150758 | 000 |
| 00810008211564 | K150758 | 000 |
| 00810008211557 | K150758 | 000 |
| 00810008214176 | K150758 | 000 |
| 00810008214145 | K150758 | 000 |
| 16971564467480 | K150758 | 000 |
| 16971564467497 | K150758 | 000 |
| 00616784893822 | K150758 | 000 |
| 00616784893723 | K150758 | 000 |
| 00616784893631 | K150758 | 000 |
| 00616784890524 | K150758 | 000 |
| 00616784890425 | K150758 | 000 |
| 00616784890326 | K150758 | 000 |
| 00616784890227 | K150758 | 000 |
| 00616784890128 | K150758 | 000 |
| 00888277726652 | K150758 | 000 |
| 20888277657301 | K150758 | 000 |
| 20888277657295 | K150758 | 000 |
| 16971564467541 | K150758 | 000 |
| 16971564467534 | K150758 | 000 |
| 16971564467527 | K150758 | 000 |
| 00810008214114 | K150758 | 000 |