Safety Insulin Pen Needle

Needle, Hypodermic, Single Lumen

Jiangsu Caina Medical Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Safety Insulin Pen Needle.

Pre-market Notification Details

Device IDK192677
510k NumberK192677
Device Name:Safety Insulin Pen Needle
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Jiangsu Caina Medical Co., Ltd. No.3, Huanxi Road, Zhutang Town Jiangyin,  CN 214415
ContactJianwei Pan
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd. P.O. BOX 120-119 Shanghai,  CN 200120
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2020-02-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.