The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Disposable Sterile Needle.
| Device ID | K172938 |
| 510k Number | K172938 |
| Device Name: | Disposable Sterile Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214425 |
| Contact | Jun Lu |
| Correspondent | Diana Hong Mid-link Consulting Co., Ltd P.O.Box 120-119 Shanghai, CN 200120 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850060997294 | K172938 | 000 |
| 10850060997355 | K172938 | 000 |
| 10850060997362 | K172938 | 000 |
| 10850060997379 | K172938 | 000 |
| 10850060997386 | K172938 | 000 |
| 10850041572182 | K172938 | 000 |
| 10850041572199 | K172938 | 000 |
| 10850041572212 | K172938 | 000 |
| 10850041572229 | K172938 | 000 |
| 10850060997348 | K172938 | 000 |
| 10850060997331 | K172938 | 000 |
| 10850060997324 | K172938 | 000 |
| 10850060997300 | K172938 | 000 |
| 10850060997317 | K172938 | 000 |
| 10850060997393 | K172938 | 000 |
| 10850060997409 | K172938 | 000 |
| 10850060997256 | K172938 | 000 |
| 10850060997263 | K172938 | 000 |
| 00850060997273 | K172938 | 000 |
| 10850060997287 | K172938 | 000 |
| 10850041572236 | K172938 | 000 |
| 10850041572243 | K172938 | 000 |
| 10850041572366 | K172938 | 000 |
| 10850041572373 | K172938 | 000 |
| 10850041572380 | K172938 | 000 |
| 10850041572397 | K172938 | 000 |
| 10850041572403 | K172938 | 000 |
| 10850041572410 | K172938 | 000 |
| 10850041572427 | K172938 | 000 |
| 00853602008604 | K172938 | 000 |
| 10850041572359 | K172938 | 000 |
| 10850041572342 | K172938 | 000 |
| 10850041572335 | K172938 | 000 |
| 10850041572250 | K172938 | 000 |
| 10850041572267 | K172938 | 000 |
| 10850041572274 | K172938 | 000 |
| 10850041572281 | K172938 | 000 |
| 10850041572298 | K172938 | 000 |
| 10850041572304 | K172938 | 000 |
| 10850041572311 | K172938 | 000 |
| 10850041572328 | K172938 | 000 |
| 00853602008611 | K172938 | 000 |