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FDA 510(k) Application Details - K140804
Device Classification Name
System, Catheter Control, Steerable
More FDA Info for this Device
510(K) Number
K140804
Device Name
System, Catheter Control, Steerable
Applicant
STEREOTAXIS, INC.
2995 STEVEN MARTIN DR,
FAIRFAX, VA 22031 US
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Contact
DIANE HORWITZ, PH.D., RAC
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Regulation Number
870.1290
More FDA Info for this Regulation Number
Classification Product Code
DXX
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More FDA Info for this Product Code
Date Received
03/31/2014
Decision Date
09/03/2014
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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