TK Safety Needle

Needle, Hypodermic, Single Lumen

Anhui Tiankang Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Anhui Tiankang Medical Technology Co., Ltd. with the FDA for Tk Safety Needle.

Pre-market Notification Details

• Device ID: K191644
• 510k Number: K191644
• Device Name: TK Safety Needle
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: Anhui Tiankang Medical Technology Co., Ltd. No.228 Weiyi Road, Economic Development Zone Tianchang, CN 239300
• Contact: Bai Baodong
• Correspondent: Bai Baodong; Anhui Tiankang Medical Technology Co., Ltd. No.228 Weiyi Road, Economic Development Zone Tianchang, CN 239300
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-19
• Decision Date: 2020-08-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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