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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Check Valve, Retrograde Flow (In-Line)
510(k) Number K861586
Device Name LOPEZ VALVE
Applicant
Icu Medical, Inc.
5200 Warner Ave., Suite 108
Huntington Beach,  CA  92649
Applicant Contact GEORGE A LOPEZ
Correspondent
Icu Medical, Inc.
5200 Warner Ave., Suite 108
Huntington Beach,  CA  92649
Correspondent Contact GEORGE A LOPEZ
Regulation Number880.5440
Classification Product Code
MJF  
Date Received04/29/1986
Decision Date 08/18/1986
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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