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FDA 510(k) Application Details - K060954
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K060954
Device Name
Computer, Diagnostic, Programmable
Applicant
ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS
1350 ENERGY LN., SUITE 110
ST. PAUL, MN 55108-5254 US
Other 510(k) Applications for this Company
Contact
KAREN J MCKELVEY
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/07/2006
Decision Date
04/21/2006
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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