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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 K021692
Device Name CLC2000 CATHETER PATENCY DEVICE
Applicant
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Applicant Contact ALISON D BURCAR
Correspondent
ICU MEDICAL, INC.
951 CALLE AMANECER
SAN CLEMENTE,  CA  92673
Correspondent Contact ALISON D BURCAR
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/22/2002
Decision Date 12/04/2003
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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