Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle With Holder, Safety Blood Collecting Needle With Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set With Holder, Safety Blood Collecting Set

Needle, Hypodermic, Single Lumen

Zhejiang Kindley Medical Devices Co.,Ltd

The following data is part of a premarket notification filed by Zhejiang Kindley Medical Devices Co.,ltd with the FDA for Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle With Holder, Safety Blood Collecting Needle With Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set With Holder, Safety Blood Collecting Set.

Pre-market Notification Details

• Device ID: K172763
• 510k Number: K172763
• Device Name: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle With Holder, Safety Blood Collecting Needle With Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set With Holder, Safety Blood Collecting Set
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: Zhejiang Kindley Medical Devices Co.,Ltd No.758, 5th Binhai Road, Binhai Industrial Park, Longwan District Wenzhou, CN 325025
• Contact: Yong Zhang
• Correspondent: Diana Hong; Mid-Link Consulting Co.,Ltd P.O.Box 120-119 Shanghai, CN 325025
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-13
• Decision Date: 2018-06-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810008211748	K172763	000
10850028131050	K172763	000
10850028131067	K172763	000
10850028131074	K172763	000
10850028131081	K172763	000
10850028131098	K172763	000
40612479244458	K172763	000
40612479244472	K172763	000
10085002813107	K172763	000
10085002813114	K172763	000
10085002813121	K172763	000
10850028131043	K172763	000
10850028131036	K172763	000
00810008211786	K172763	000
00810008212875	K172763	000
00810008212905	K172763	000
00810008212936	K172763	000
00810008212950	K172763	000
00850048235014	K172763	000
00850048235021	K172763	000
10850028131005	K172763	000
10850028131012	K172763	000
10850028131029	K172763	000
10085002813138	K172763	000
10085002813145	K172763	000
00811220033408	K172763	000
00811220033392	K172763	000
20304040132382	K172763	000
40612479258813	K172763	000
40612479258844	K172763	000
40612479244342	K172763	000
40612479244373	K172763	000
40612479244403	K172763	000
40612479244434	K172763	000
40612479244502	K172763	000
10850028131166	K172763	000
10850028131159	K172763	000
10085002813152	K172763	000
10085002813169	K172763	000
10085002813176	K172763	000
10085002813183	K172763	000
10085002813190	K172763	000
10850028131104	K172763	000
10850028131111	K172763	000
10850028131128	K172763	000
10850028131135	K172763	000
10850028131142	K172763	000
40612479244533	K172763	000