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FDA 510(k) Application Details - K021555
Device Classification Name
System, Catheter Control, Steerable
More FDA Info for this Device
510(K) Number
K021555
Device Name
System, Catheter Control, Steerable
Applicant
STEREOTAXIS, INC.
4041 FOREST PARK AVE.
ST. LOUIS, MO 63108 US
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Contact
PETER A TAKES
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Regulation Number
870.1290
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Classification Product Code
DXX
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More FDA Info for this Product Code
Date Received
05/13/2002
Decision Date
01/15/2003
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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