RG 3ml Medication Cartridge

Accessories, Pump, Infusion

Chengdu Shifeng Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Chengdu Shifeng Medical Technology Co., Ltd. with the FDA for Rg 3ml Medication Cartridge.

Pre-market Notification Details

Device IDK201634
510k NumberK201634
Device Name:RG 3ml Medication Cartridge
ClassificationAccessories, Pump, Infusion
Applicant Chengdu Shifeng Medical Technology Co., Ltd. No. 31, Yinyuan Road Jinhua Town, Xinjin County,  CN 611438
ContactNick Wang
CorrespondentMaureen O'connell
O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham,  MA  02180
Product CodeMRZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-16
Decision Date2021-03-26

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