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FDA 510(k) Application Details - K141453
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K141453
Device Name
Catheter, Intravascular, Diagnostic
Applicant
LIGHTLAB IMAGING, INC.
4 ROBBINS ROAD
WESTFORD, MA 01886 US
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Contact
JEFFREY ROBERTS
Other 510(k) Applications for this Contact
Regulation Number
870.1200
More FDA Info for this Regulation Number
Classification Product Code
DQO
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More FDA Info for this Product Code
Date Received
06/02/2014
Decision Date
09/19/2014
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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