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FDA 510(k) Application Details - K113335
Device Classification Name
Catheter, Intravascular, Diagnostic
More FDA Info for this Device
510(K) Number
K113335
Device Name
Catheter, Intravascular, Diagnostic
Applicant
TERUMO Corporation
44-1, 2-CHOME HATAGAYA
SHIBUYA-KU TOKYO 151-0072 JP
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Contact
MARK UNTERREINER
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
11/14/2011
Decision Date
07/16/2012
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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