YI XIN STERILE SYRINGE FOR SINGLE USE

Syringe, Piston

JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP

The following data is part of a premarket notification filed by Jiangxi Sanxin (eversincere) Medical Devices Group with the FDA for Yi Xin Sterile Syringe For Single Use.

Pre-market Notification Details

Device IDK050999
510k NumberK050999
Device Name:YI XIN STERILE SYRINGE FOR SINGLE USE
ClassificationSyringe, Piston
Applicant JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP SHANJIANG ROAD Nanchang, Jiangxi,  CN 330204
ContactYun Yuan Gao
CorrespondentYun Yuan Gao
JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP SHANJIANG ROAD Nanchang, Jiangxi,  CN 330204
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-20
Decision Date2005-09-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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