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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K042117
Device Name PROXIS SYSTEM, MODEL EPS 101
Applicant
VELOCIMED INC.
6550 WEDGWOOD RD. NORTH
SUITE 150
MINNEAPOLIS,  MN  55311
Applicant Contact JOHN CARLINE
Correspondent
VELOCIMED INC.
6550 WEDGWOOD RD. NORTH
SUITE 150
MINNEAPOLIS,  MN  55311
Correspondent Contact JOHN CARLINE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/05/2004
Decision Date 01/07/2005
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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