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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 Lane
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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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