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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilization wrap containers, trays, cassettes & other accessories
510(k) Number K201878
Device Name ST-Z5
Applicant
Z-Systems AG
Werkhofstrasse 5
Oensingen,  CH ch-4702
Applicant Contact Rubino DiGirolamo
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A Thomas
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/07/2020
Decision Date 03/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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