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FDA 510(k) Application Details - K070011
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K070011
Device Name
Catheter, Intravascular, Diagnostic
Applicant
IRVINE BIOMEDICAL,INC.(IBI)
2375 MORSE AVE.
IRVINE, CA 92614 US
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Contact
ROHIT PATEL
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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
01/03/2007
Decision Date
03/20/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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