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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 K063182
Device Name ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX
Applicant
ENPATH MEDICAL, INC.
15301 HWY. 55 WEST
MINNEAPOLIS,  MN  55447
Applicant Contact JAMES JENKINS
Correspondent
ENPATH MEDICAL, INC.
15301 HWY. 55 WEST
MINNEAPOLIS,  MN  55447
Correspondent Contact JAMES JENKINS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/19/2006
Decision Date 12/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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