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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 K964859
Device Name SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
Applicant
SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact ANGELA RAUN
Correspondent
SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact ANGELA RAUN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/04/1996
Decision Date 02/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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