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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 K943777
Device Name SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER
Applicant
SCIMED LIFE SYSTEMS, INC.
8200 SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact DIANE M LOWE
Correspondent
SCIMED LIFE SYSTEMS, INC.
8200 SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact DIANE M LOWE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/02/1994
Decision Date 10/13/1994
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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