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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 K970823
Device Name SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER
Original Applicant
SCIMED LIFE SYSTEMS, INC.
one scimed place
maple grove,  MN  55311 1566
Original Contact angela ruan
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/06/1997
Decision Date 06/03/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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