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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 K051437
Device Name CML 1000
Applicant
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Applicant Contact JIM COOMBES
Correspondent
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Correspondent Contact JIM COOMBES
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/01/2005
Decision Date 08/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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