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FDA 510(k) Application Details - K052899
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
510(K) Number
K052899
Device Name
Ring, Annuloplasty
Applicant
Genesee BioMedical, Inc.
1308 SOUTH JASON ST.
DENVER, CO 80223 US
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Contact
JOHN T.M. WRIGHT
Other 510(k) Applications for this Contact
Regulation Number
870.3800
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Classification Product Code
KRH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/14/2005
Decision Date
11/17/2005
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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