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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 K161815
Device Name FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
Applicant
Genesee Biomedical, Inc.
700 W. Mississippi Ave., Unit D-5
Denver,  CO  80223
Applicant Contact Woodrow G. Mathison
Correspondent
Genesee Biomedical, Inc.
700 W. Mississippi Ave., Unit D-5
Denver,  CO  80223
Correspondent Contact Woodrow G. Mathison
Regulation Number870.3800
Classification Product Code
KRH  
Date Received07/01/2016
Decision Date 10/12/2016
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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