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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 K961280
Device Name SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
Original Applicant
SCIMED LIFE SYSTEMS, INC.
one scimed place
maple grove,  MN  55311 -1566
Original Contact angela raun
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/03/1996
Decision Date 05/15/1996
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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