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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Left Atrial Appendage Clip, Implantable
510(k) Number K220305
Device Name Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
Applicant
Syntheon
13755 SW 119 Ave.
Miami,  FL  33186
Applicant Contact Sean McBryer
Correspondent
Caraballo Consulting, LLC
11037 Bitternut Hickory Ln.
Boynton Beach,  FL  33437
Correspondent Contact Elena Jugo
Regulation Number878.4300
Classification Product Code
PZX  
Date Received02/02/2022
Decision Date 10/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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