Hypodermic Safety Needle, Hypodermic Safety Needle With Syringe

Syringe, Antistick

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

The following data is part of a premarket notification filed by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. with the FDA for Hypodermic Safety Needle, Hypodermic Safety Needle With Syringe.

Pre-market Notification Details

• Device ID: K190183
• 510k Number: K190183
• Device Name: Hypodermic Safety Needle, Hypodermic Safety Needle With Syringe
• Classification: Syringe, Antistick
• Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. No. 2 Guanyin Road Economic Development Zone Taihu, Anqing City, CN 246400
• Contact: Gang Yu
• Correspondent: Charles Mack; IRC 2950 E Lindrick Drive Chandler, AZ 85249
• Product Code: MEG
• Subsequent Product Code: FMF
• Subsequent Product Code: FMI
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-01
• Decision Date: 2019-10-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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G018SN25381	K190183	000
G018SN25251	K190183	000
G018SN23381	K190183	000
G018SN23251	K190183	000
G018SLL32538SN1	K190183	000
G018SLL32525SN1	K190183	000
G018SLL12538SN1	K190183	000
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