EasyEndo Linear Cutting Stapler And Loading Unit For Single Use(Stapler;Loading Unit)

Staple, Implantable

EziSurg Medical Co.,Ltd.

The following data is part of a premarket notification filed by Ezisurg Medical Co.,ltd. with the FDA for Easyendo Linear Cutting Stapler And Loading Unit For Single Use(stapler;loading Unit).

Pre-market Notification Details

Device IDK143129
510k NumberK143129
Device Name:EasyEndo Linear Cutting Stapler And Loading Unit For Single Use(Stapler;Loading Unit)
ClassificationStaple, Implantable
Applicant EziSurg Medical Co.,Ltd. Room 312, Bldg 2, No.1690 Cailun Road Zhangjiang High-Tech Park,Pudong Shanghai,  CN 201203
ContactJohnny Yan
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd. P.O.Box 120-119 Shanghai,  CN 200120
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-31
Decision Date2015-01-29
Summary:summary

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