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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
Correspodent 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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