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FDA 510(k) Application Details - K120008
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K120008
Device Name
Catheter, Intravascular, Diagnostic
Applicant
MEDLINE, INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact
MATT CLAUSEN
Other 510(k) Applications for this Contact
Regulation Number
870.1200
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Classification Product Code
DQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/03/2012
Decision Date
08/17/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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