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FDA 510(k) Application Details - K053171
Device Classification Name
Catheter, Intravascular, Diagnostic
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510(K) Number
K053171
Device Name
Catheter, Intravascular, Diagnostic
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN, UT 84095 US
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Contact
STEPHANIE ERSKINE
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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
11/14/2005
Decision Date
01/19/2006
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
Y
Expedited Review
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