3D Visualization System

Laparoscope, General & Plastic Surgery

Scivita Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Scivita Medical Technology Co., Ltd with the FDA for 3d Visualization System.

Pre-market Notification Details

Device IDK183675
510k NumberK183675
Device Name:3D Visualization System
ClassificationLaparoscope, General & Plastic Surgery
Applicant Scivita Medical Technology Co., Ltd No.8, Zhong Tian Xiang, Suzhou Industrial Park Suzhou,  CN 215000
ContactRuqin Wu
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai,  CN 200120
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-28
Decision Date2019-09-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971381250053 K183675 000
06971381250046 K183675 000
06971381250039 K183675 000
06971381250022 K183675 000
06971381250015 K183675 000

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