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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 K040150
Device Name MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
Applicant
MEDAMICUS, INC.
15301 HWY. 55 WEST
MINNEAPOLIS,  MN  55447
Applicant Contact KARYL HASKELL
Correspondent
MEDAMICUS, INC.
15301 HWY. 55 WEST
MINNEAPOLIS,  MN  55447
Correspondent Contact KARYL HASKELL
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/23/2004
Decision Date 02/18/2004
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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