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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K071574
Device Name STIFFER COAXIAL MICRO-INTRODUCER KIT
Original Applicant
ENPATH MEDICAL, INC.
2300 berkshire lane north
minneapolis,  MN  55441
Original Contact patrice stromberg
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/08/2007
Decision Date 07/05/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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