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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K771432
Device Name HICALIQ IVH BAG
Applicant
Terumo America, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Terumo America, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5025
Classification Product Code
KPE  
Date Received08/01/1977
Decision Date 09/28/1977
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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