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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 K072248
Device Name VIAPEEL PEELABLE INTRODUCER
Original Applicant
ENPATH MEDICAL, INC.
2300 berkshire lane north
minneapolis,  MN  55441
Original Contact patrice stromberg
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/13/2007
Decision Date 11/09/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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