Disposable Sterile 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 Disposable Sterile Needle.

Pre-market Notification Details

• Device ID: K172938
• 510k Number: K172938
• Device Name: Disposable Sterile Needle
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214425
• Contact: Jun Lu
• 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: 2017-09-26
• Decision Date: 2018-06-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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10850060997263	K172938	000
00850060997273	K172938	000
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