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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
510(k) Number K243233
Device Name esolution® Esophageal Retractor
Applicant
S4 Medical Corp.
34 S. Main St., Suite 200
Chagrin Falls,  OH  44022
Applicant Contact William Fuller
Correspondent
ProPharma MedTech
1129 20th St. NW Suite 600
Washington,  DC  20036
Correspondent Contact Jennifer Daudelin
Classification Product Code
QXU  
Date Received10/09/2024
Decision Date 11/09/2024
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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