Autokeeper

Needle, Hypodermic, Single Lumen

MedExel Co.,Ltd.

The following data is part of a premarket notification filed by Medexel Co.,ltd. with the FDA for Autokeeper.

Pre-market Notification Details

• Device ID: K172095
• 510k Number: K172095
• Device Name: Autokeeper
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: MedExel Co.,Ltd. 252, Geumgwangosan-ro, Geumgwang-myeon Anseong-si, KR 17535
• Contact: Cha Dong Ik
• Correspondent: Peter Chung; Plus Global 300 Atwood Pittsburgh, PA 15213
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-11
• Decision Date: 2018-07-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18809445831533	K172095	000
18809445831397	K172095	000
18809445831380	K172095	000
18809445831373	K172095	000
18809445831366	K172095	000
18809445831359	K172095	000
18809445831342	K172095	000
18809445831335	K172095	000
18809445831328	K172095	000
18809445831311	K172095	000
18809445831304	K172095	000
18809445831403	K172095	000
18809445831410	K172095	000
18809445831526	K172095	000
18809445831519	K172095	000
18809445831502	K172095	000
18809445831496	K172095	000
18809445831489	K172095	000
18809445831472	K172095	000
18809445831465	K172095	000
18809445831458	K172095	000
18809445831441	K172095	000
18809445831434	K172095	000
28809445831295	K172095	000