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FDA 510(k) Application Details - K022004
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K022004
Device Name
Catheter, Intravascular, Diagnostic
Applicant
BIOSENSORS INTERNATIONAL-USA
20250 ACACIA ST., SUITE 115
NEWPORT BEACH, CA 92660 US
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Contact
JORGE HAIDER
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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
06/19/2002
Decision Date
03/12/2003
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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