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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 K913476
Device Name GI BLEEDER/OD SET
Applicant
Icu Medical, Inc.
142 Technology Dr.
Irvine,  CA  92718
Applicant Contact ARACELI C FANCHER
Correspondent
Icu Medical, Inc.
142 Technology Dr.
Irvine,  CA  92718
Correspondent Contact ARACELI C FANCHER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/05/1991
Decision Date 02/12/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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