The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Safety Insulin Pen Needle.
| Device ID | K192677 |
| 510k Number | K192677 |
| Device Name: | Safety Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Jiangsu Caina Medical Co., Ltd. No.3, Huanxi Road, Zhutang Town Jiangyin, CN 214415 |
| Contact | Jianwei Pan |
| 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 | 2019-09-26 |
| Decision Date | 2020-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850027494446 | K192677 | 000 |
| 00850053135705 | K192677 | 000 |
| 00850053135712 | K192677 | 000 |
| 00850053135729 | K192677 | 000 |
| 00850053135736 | K192677 | 000 |
| 00810008211939 | K192677 | 000 |
| 00810008212103 | K192677 | 000 |
| 00369771003390 | K192677 | 000 |
| 00850027494425 | K192677 | 000 |
| 10850027494439 | K192677 | 000 |
| 00850053135699 | K192677 | 000 |