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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 K895437
Device Name SCIMED CORONARY GUIDING CATHETER
Applicant
SCIMED LIFE SYSTEMS, INC.
6655 WEDGWOOD RD.
MAPLE GROVE,  MN  55369
Applicant Contact DARLENE A THOMETZ
Correspondent
SCIMED LIFE SYSTEMS, INC.
6655 WEDGWOOD RD.
MAPLE GROVE,  MN  55369
Correspondent Contact DARLENE A THOMETZ
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/08/1989
Decision Date 06/28/1990
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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