SUMMED INFLATION DEVICE KIT

Syringe, Balloon Inflation

SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD

The following data is part of a premarket notification filed by Sunny Medical Device (shenzhen) Co., Ltd with the FDA for Summed Inflation Device Kit.

Pre-market Notification Details

Device IDK133795
510k NumberK133795
Device Name:SUMMED INFLATION DEVICE KIT
ClassificationSyringe, Balloon Inflation
Applicant SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD 56 LEHIGH AISLE Irvine,  CA  92612
ContactJames Qi Zhang
CorrespondentJames Qi Zhang
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD 56 LEHIGH AISLE Irvine,  CA  92612
Product CodeMAV  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-13
Decision Date2014-12-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06947358563006 K133795 000
06947358563402 K133795 000

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