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FDA 510(k) Application Details - K041708
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K041708
Device Name
Introducer, Catheter
Applicant
ENPATH MEDICAL INCORPORATED
15301 HWY. 55 WEST
MINNEAPOLIS, MN 55447 US
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Contact
KARYL HASKELL
Other 510(k) Applications for this Contact
Regulation Number
870.1340
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Classification Product Code
DYB
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More FDA Info for this Product Code
Date Received
06/23/2004
Decision Date
11/30/2004
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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