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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K080007
Device Name GRADUATED ADAPTER WITH CLAVE
Applicant
Icu Medical, Inc.
4455 Atherton Dr.
Salt Lake City,  UT  84123
Applicant Contact TRACY BEST
Correspondent
Icu Medical, Inc.
4455 Atherton Dr.
Salt Lake City,  UT  84123
Correspondent Contact TRACY BEST
Regulation Number876.5130
Classification Product Code
EZD  
Subsequent Product Code
KNY  
Date Received01/02/2008
Decision Date 05/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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