Looking Glass 4K Integrated Visualization System

Laparoscope, General & Plastic Surgery

ConMed Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Looking Glass 4k Integrated Visualization System.

Pre-market Notification Details

Device IDK201593
510k NumberK201593
Device Name:Looking Glass 4K Integrated Visualization System
ClassificationLaparoscope, General & Plastic Surgery
Applicant ConMed Corporation 525 French Road Utica,  NY  13502
ContactKavita Amin
CorrespondentKavita Amin
ConMed Corporation 525 French Road Utica,  NY  13502
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-12
Decision Date2020-07-08

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