Inflation Device

Syringe, Balloon Inflation

SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.

The following data is part of a premarket notification filed by Shanghai Kindly Medical Instruments Co.,ltd. with the FDA for Inflation Device.

Pre-market Notification Details

Device IDK170027
510k NumberK170027
Device Name:Inflation Device
ClassificationSyringe, Balloon Inflation
Applicant SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. NO. 925 JINYUAN YI RD Shanghai,  CN 201803
ContactXu Jianhai
CorrespondentJeffery Hui
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. NO. 925 JINYUAN YI RD Shanghai,  CN 201803
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-03
Decision Date2017-10-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850004162040 K170027 000
26950900920039 K170027 000
26950900920015 K170027 000
20197344013781 K170027 000
20197344104939 K170027 000

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