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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 K021004
Device Name VALVED 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 Received03/28/2002
Decision Date 06/06/2002
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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