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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 K934581
Device Name SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS
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  
Subsequent Product Code
DQY  
Date Received09/23/1993
Decision Date 03/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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