YIXIN SAFETY SYRINGE

Syringe, Antistick

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 Yixin Safety Syringe.

Pre-market Notification Details

Device IDK042102
510k NumberK042102
Device Name:YIXIN SAFETY SYRINGE
ClassificationSyringe, Antistick
Applicant JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP SHAN JIANG ZHEN ROAD Nan Chang, Jiangxi,  CN 330204
ContactLiu Kun Sheng
CorrespondentLiu Kun Sheng
JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP SHAN JIANG ZHEN ROAD Nan Chang, Jiangxi,  CN 330204
Product CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-04
Decision Date2005-03-08

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