Sterile Syringe For Single Use

Syringe, Piston

Jiangsu Suyun Medical Material Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Suyun Medical Material Co., Ltd. with the FDA for Sterile Syringe For Single Use.

Pre-market Notification Details

Device IDK210914
510k NumberK210914
Device Name:Sterile Syringe For Single Use
ClassificationSyringe, Piston
Applicant Jiangsu Suyun Medical Material Co., Ltd. No.18 Jinqiao Road, Dapu Industrial Park Lianyungang,  CN 222000
ContactGuangning Xu
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-29
Decision Date2021-12-17

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