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FDA 510(k) Application Details - K032494
Device Classification Name
Catheter, Continuous Flush
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510(K) Number
K032494
Device Name
Catheter, Continuous Flush
Applicant
PRECISION VASCULAR SYSTEMS, INC.
2405 WEST ORTON CIR.
WEST VALLEY CITY, UT 84119 US
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Contact
RICK GAYKOWSKI
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Regulation Number
870.1210
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Classification Product Code
KRA
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More FDA Info for this Product Code
Date Received
08/13/2003
Decision Date
09/05/2003
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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