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FDA 510(k) Application Details - K945586
Device Classification Name
Dilator, Vessel, For Percutaneous Catheterization
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510(K) Number
K945586
Device Name
Dilator, Vessel, For Percutaneous Catheterization
Applicant
MED INSTITUTE, INC.
P.O. BOX 2402
WEST LAFAYETTE, IN 47906 US
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NEAL E FEARNOT
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Regulation Number
870.1310
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Classification Product Code
DRE
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More FDA Info for this Product Code
Date Received
11/14/1994
Decision Date
04/04/1997
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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