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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K070633
Device Name GENIE, MODEL CH-200
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 Number880.5860
Classification Product Code
FMF  
Date Received03/07/2007
Decision Date 06/05/2007
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
Predetermined Change
Control Plan Authorized		 No
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