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FDA 510(k) Application Details - K973401
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K973401
Device Name
Catheter, Intravascular, Diagnostic
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014 US
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Contact
JACQUELINE ZIMOVAN
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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
09/09/1997
Decision Date
11/18/1997
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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