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FDA 510(k) Application Details - K230679
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
510(K) Number
K230679
Device Name
Ring, Annuloplasty
Applicant
Genesee Biomedical Inc
700 W. Mississippi Ave
Unit D-5
Denver, CO 80223 US
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Contact
Woodrow Mathison
Other 510(k) Applications for this Contact
Regulation Number
870.3800
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Classification Product Code
KRH
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More FDA Info for this Product Code
Date Received
03/13/2023
Decision Date
05/26/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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