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FDA 510(k) Application Details - K011664
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K011664
Device Name
Catheter, Intravascular, Diagnostic
Applicant
BOSTON SCIENTIFIC/MEDI-TECH
ONE BOSTON SCIENTIFIC PLACE
NATICK, MA 01760-1537 US
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Contact
JODI L GREENIZEN
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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
05/30/2001
Decision Date
09/07/2001
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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