Unimicro Trocar Kit, Models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar

Laparoscope, General & Plastic Surgery

UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.

The following data is part of a premarket notification filed by Unimicro Medical Systems (shenzhen) Co., Ltd. with the FDA for Unimicro Trocar Kit, Models: Auto-locking Trocar, Hasson Trocar, Bladeless Trocar.

Pre-market Notification Details

Device IDK141594
510k NumberK141594
Device Name:Unimicro Trocar Kit, Models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
ClassificationLaparoscope, General & Plastic Surgery
Applicant UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. R15-08, EAST BUILDING, YIHAI PLAZA, CHUANGYE ROADS, NANSHAN DISTRICT Shenzhen, Guangdong,  CN 518054
ContactLong Yang
CorrespondentLong Yang
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. R15-08, EAST BUILDING, YIHAI PLAZA, CHUANGYE ROADS, NANSHAN DISTRICT Shenzhen, Guangdong,  CN 518054
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-13
Decision Date2015-08-10
Summary:summary

NIH GUDID Devices

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