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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 K081394
Device Name PTFE INTERLOCK PEELABLE INTRODUCERS
Original Applicant
ENPATH MEDICAL, INC.
2300 berkshire lane north
minneapolis,  MN  55441
Original Contact shannon springer
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/19/2008
Decision Date 09/15/2008
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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