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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K052594
Device Name WILLCARE, MODEL GW-1020
Applicant
Icu Medical, Inc.
16787 Bernardo Center Dr.,
Suite A-1
San Diego,  CA  92128
Applicant Contact SCOTT NELSON
Correspondent
Underwriters Laboratories, Inc.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/21/2005
Decision Date 02/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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