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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 K033290
Device Name TALON INFUSION SET, MODEL IP XXXX
Applicant
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Applicant Contact DALE FAIRCHILD
Correspondent
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Correspondent Contact DALE FAIRCHILD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/14/2003
Decision Date 04/12/2004
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
Recalls CDRH Recalls
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