Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Z-Systems AG

The following data is part of a premarket notification filed by Z-systems Ag with the FDA for St-z5.

Pre-market Notification Details

Device IDK201878
510k NumberK201878
Device Name:ST-Z5
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Z-Systems AG Werkhofstrasse 5 Oensingen,  CH Ch-4702
ContactRubino Digirolamo
CorrespondentKevin A Thomas
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-07
Decision Date2021-03-25

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