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 |
10850058864010 | K192677 | 000 |
10850058864027 | K192677 | 000 |
00850053135699 | 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 |
00850058864006 | K192677 | 000 |