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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K203179
Device Name Fortress Introducer Sheath System
Applicant
Contract Medical International GmbH
Lauensteiner Strasse 37
Dresden,  DE 01277
Applicant Contact Marketa Shanelova
Correspondent
Contract Medical International GmbH
Lauensteiner Strasse 37
Dresden,  DE 01277
Correspondent Contact Marketa Shanelova
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DRE  
Date Received10/26/2020
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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