Sterile Disposable Syringe With Safety Needle, Sterile Disposable Syringe With Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle

Syringe, Antistick

Yangzhou Medline Industry Co., Ltd.

The following data is part of a premarket notification filed by Yangzhou Medline Industry Co., Ltd. with the FDA for Sterile Disposable Syringe With Safety Needle, Sterile Disposable Syringe With Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle.

Pre-market Notification Details

• Device ID: K170651
• 510k Number: K170651
• Device Name: Sterile Disposable Syringe With Safety Needle, Sterile Disposable Syringe With Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
• Classification: Syringe, Antistick
• Applicant: Yangzhou Medline Industry Co., Ltd. No. 108, Jinshan Road, Economic Development Zone Yangzhou, CN 225000
• Contact: Jianzhong Qi
• Correspondent: Diana Hong; Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120
• 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: 2017-03-03
• Decision Date: 2017-08-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20850053289624	K170651	000
20850044799125	K170651	000
20850044799132	K170651	000
20850044799149	K170651	000
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20850044799163	K170651	000
30850044799177	K170651	000
30850044799184	K170651	000
30850044799191	K170651	000
20850044799200	K170651	000
20850044799224	K170651	000
20850044799231	K170651	000
20850044799248	K170651	000
20850044799118	K170651	000
20850044799101	K170651	000
20850044799095	K170651	000
20850053289631	K170651	000
20850053289648	K170651	000
20850053289662	K170651	000
30850044799009	K170651	000
20850044799019	K170651	000
20850044799026	K170651	000
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20850044799040	K170651	000
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20850044799064	K170651	000
20850044799071	K170651	000
20850044799088	K170651	000
20850044799255	K170651	000
20850044799262	K170651	000
20850044799422	K170651	000
20850044799439	K170651	000
20850044799446	K170651	000
20850044799453	K170651	000
20850044799460	K170651	000
20850044799477	K170651	000
20850044799484	K170651	000
20850044799491	K170651	000
20850044799507	K170651	000
20850044799514	K170651	000
20850044799521	K170651	000
20850044799545	K170651	000
20850044799415	K170651	000
20850044799408	K170651	000
20850044799392	K170651	000
20850044799279	K170651	000
20850044799286	K170651	000
20850044799293	K170651	000
20850044799309	K170651	000
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20850044799354	K170651	000
20850044799361	K170651	000
20850044799378	K170651	000
20850044799385	K170651	000
40850044799211	K170651	000