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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K082806
Device Name SPINNING SPIROS, MODEL CH-2000
Applicant
ICU MEDICAL, INC
4455 ATHERTON DR.
SALT LAKE CITY,  UT  84123
Applicant Contact TRACY BEST
Correspondent
ICU MEDICAL, INC
4455 ATHERTON DR.
SALT LAKE CITY,  UT  84123
Correspondent Contact TRACY BEST
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/24/2008
Decision Date 04/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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