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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
Applicant
ENPATH MEDICAL, INC.
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS,  MN  55441
Applicant Contact SHANNON SPRINGER
Correspondent
ENPATH MEDICAL, INC.
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS,  MN  55441
Correspondent Contact SHANNON SPRINGER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/19/2008
Decision Date 09/15/2008
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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