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FDA 510(k) Application Details - K052865
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K052865
Device Name
Catheter, Intravascular, Diagnostic
Applicant
ICU MEDICAL, INC.
275 North Field Drive
Lake Forest, IL 60045 US
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Contact
TOM KOZMA
Other 510(k) Applications for this Contact
Regulation Number
870.1200
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Classification Product Code
DQO
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More FDA Info for this Product Code
Date Received
10/11/2005
Decision Date
12/22/2005
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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