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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medium-Term Adjunctive Predictive Cardiovascular Indicator
510(k) Number K233216
Device Name CLEWICU System
Applicant
Clew Medical , Ltd.
5 Hamelecha St.
Poleg,  IL 4250540
Applicant Contact Avidgor Faians
Correspondent
Heyer Regulatory Solutions
125 Cherry Ln.
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number870.2210
Classification Product Code
QNL  
Date Received09/28/2023
Decision Date 01/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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