Oral/Enteral Syringe (10 ML To 60 ML) And Low Dose Tip Oral/Enteral Syringe (1 ML To 5 ML)

Enteral Syringes With Enteral Specific Connectors

Jiangsu Micsafe Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Micsafe Medical Technology Co., Ltd with the FDA for Oral/enteral Syringe (10 Ml To 60 Ml) And Low Dose Tip Oral/enteral Syringe (1 Ml To 5 Ml).

Pre-market Notification Details

Device IDK181426
510k NumberK181426
Device Name:Oral/Enteral Syringe (10 ML To 60 ML) And Low Dose Tip Oral/Enteral Syringe (1 ML To 5 ML)
ClassificationEnteral Syringes With Enteral Specific Connectors
Applicant Jiangsu Micsafe Medical Technology Co., Ltd Xituan Industrial Park, Dafeng District Yancheng,  CN 224125
ContactTony Yang
CorrespondentHelen Nan
Wenzhou Cytech Information Service Co., Ltd. Room302, Building 3, Hangqian Street Lucheng District Wenzhou,  CN 325000
Product CodePNR  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-31
Decision Date2018-10-11
Summary:summary

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