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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tracking, Soft Tissue, Intraoperative
510(k) Number K143024
Device Name CAS-One Liver
Applicant
Cascination AG
Stauffacherstrasse 78
Bern,  CH 3014
Applicant Contact Matthias Peterhans
Correspondent
Cascination AG
Stauffacherstrasse 78
Bern,  CH 3014
Correspondent Contact Matthias Peterhans
Regulation Number882.4560
Classification Product Code
OEW  
Date Received10/21/2014
Decision Date 04/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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