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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K202253
Device Name TruForm Sievers Annuloplasty Ring
Applicant
Genesee Biomedical, Inc.
700 W Mississippi Ave., Unit D5
Denver,  CO  80223
Applicant Contact Woodrow Mathison
Correspondent
Genesee Biomedical, Inc.
700 W Mississippi Ave., Unit D5
Denver,  CO  80223
Correspondent Contact Woodrow Mathison
Regulation Number870.3800
Classification Product Code
KRH  
Date Received08/10/2020
Decision Date 10/06/2020
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		 No
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