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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 K000472
Device Name POSI-LINK
Applicant
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Applicant Contact SALVADORE F PALOMARES
Correspondent
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Correspondent Contact SALVADORE F PALOMARES
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/14/2000
Decision Date 05/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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