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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K935654
Device Name SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH
Applicant
SCIMED LIFE SYSTEMS, INC.
2010 EAST CENTER CIRCLE
PLYMOUTH,  MN  55441 -2644
Applicant Contact DEBORAH L JENSEN
Correspondent
SCIMED LIFE SYSTEMS, INC.
2010 EAST CENTER CIRCLE
PLYMOUTH,  MN  55441 -2644
Correspondent Contact DEBORAH L JENSEN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/24/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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