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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K853275
Device Name CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
Applicant
Icu Medical, Inc.
5200 Warner Ave., Suite 108
Huntington Beach,  CA  92649
Applicant Contact DWIGHT G DAVIS
Correspondent
Icu Medical, Inc.
5200 Warner Ave., Suite 108
Huntington Beach,  CA  92649
Correspondent Contact DWIGHT G DAVIS
Regulation Number880.5440
Classification Product Code
FMG  
Date Received08/05/1985
Decision Date 08/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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