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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K953133
Device Name SCIMED DISPATCH CORONARY INFUSION CATHETER
Applicant
SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact SHARON D KVISTAD
Correspondent
SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact SHARON D KVISTAD
Regulation Number870.1210
Classification Product Code
KRA  
Date Received07/06/1995
Decision Date 02/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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