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FDA 510(k) Application Details - K072655
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
510(K) Number
K072655
Device Name
Ring, Annuloplasty
Applicant
Genesee BioMedical, Inc.
1308 SOUTH JASON ST.
DENVER, CO 80223 US
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Contact
JOHN T WRIGHT, PH.D.
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
09/20/2007
Decision Date
10/23/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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