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FDA 510(k) Application Details - K051561
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K051561
Device Name
Catheter, Intravascular, Diagnostic
Applicant
ASAHI INTECC CO., LTD.
1301 DOVE STREET, SUITE #350
NEWPORT BEACH, CA 92660 US
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Contact
YOSHI TERAI
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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
06/13/2005
Decision Date
11/02/2005
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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