JAMBRO Single Core A Sterilization Wrap

Wrap, Sterilization

Jiangsu Zhande Medical Supplies Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Zhande Medical Supplies Co., Ltd with the FDA for Jambro Single Core A Sterilization Wrap.

Pre-market Notification Details

Device IDK182656
510k NumberK182656
Device Name:JAMBRO Single Core A Sterilization Wrap
ClassificationWrap, Sterilization
Applicant Jiangsu Zhande Medical Supplies Co., Ltd Nanjing Binjiang Economic Development Park #719 Shengan Avenue, 1/F Build. Nanjing,  CN 211178
ContactChanjuan Xu
CorrespondentJigar Shah
mdi Consultants, Inc. 55 Northern Blvd Great Neck,  NY  11021
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-25
Decision Date2019-06-11

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