FMS VUE II Fluid Management And Tissue Debridement System

Arthroscope

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Fms Vue Ii Fluid Management And Tissue Debridement System.

Pre-market Notification Details

Device IDK171237
510k NumberK171237
Device Name:FMS VUE II Fluid Management And Tissue Debridement System
ClassificationArthroscope
Applicant Medos International SARL Chemin-Blanc 38 Le Locle Neuchatel,  CH 2400
ContactTatyana Korsunsky
CorrespondentTatyana Korsunsky
DePuy Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham,  MA  02767
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-27
Decision Date2018-01-18
Summary:summary

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