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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K915171
Device Name LOPEZ VALVE TM II
Applicant
ICU MEDICAL, INC.
142 TECHNOLOGY DR.
IRVINE,  CA  92718
Applicant Contact ARACELI C FRANCHER
Correspondent
ICU MEDICAL, INC.
142 TECHNOLOGY DR.
IRVINE,  CA  92718
Correspondent Contact ARACELI C FRANCHER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/15/1991
Decision Date 02/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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