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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K052865
Device Name HOSPIRA CATH LAB CONVENIENCE KITS
Applicant
ICU MEDICAL, INC.
275 North Field Drive
Lake Forest,  IL  60045
Applicant Contact TOM KOZMA
Correspondent
ICU MEDICAL, INC.
275 North Field Drive
Lake Forest,  IL  60045
Correspondent Contact TOM KOZMA
Regulation Number870.1200
Classification Product Code
DQO  
Date Received10/11/2005
Decision Date 12/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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