Zeos Aqua Vision Pump And Tube

Arthroscope

Hemodia SAS

The following data is part of a premarket notification filed by Hemodia Sas with the FDA for Zeos Aqua Vision Pump And Tube.

Pre-market Notification Details

Device IDK192921
510k NumberK192921
Device Name:Zeos Aqua Vision Pump And Tube
ClassificationArthroscope
Applicant Hemodia SAS France Labege,  FR 31670
ContactAdeline Theron
CorrespondentArne Briest
VISAMED GmbH Kastellstr. 8 Karlsruhe,  DE 76227
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-16
Decision Date2020-10-09

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