The following data is part of a premarket notification filed by Jiangyin Caina Technology Co., Ltd with the FDA for Hard Pack Syringe.
| Device ID | K141359 |
| 510k Number | K141359 |
| Device Name: | HARD PACK SYRINGE |
| Classification | Syringe, Piston |
| Applicant | JIANGYIN CAINA TECHNOLOGY CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong JIANGYIN CAINA TECHNOLOGY CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-23 |
| Decision Date | 2014-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50192253063552 | K141359 | 000 |
| 50192253063545 | K141359 | 000 |
| 50192253035481 | K141359 | 000 |
| 50192253035429 | K141359 | 000 |
| 50192253035368 | K141359 | 000 |
| 50192253035337 | K141359 | 000 |
| 50192253035306 | K141359 | 000 |