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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name control, hemoglobin
510(k) Number K192842
Device Name HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
Applicant
Eurotrol B.V.
Keplerlaan 20
EDE,  NL 6716BS
Applicant Contact Elisanne Biemans
Correspondent
Eurotrol B.V.
Keplerlaan 20
EDE,  NL 6716BS
Correspondent Contact Elisanne Biemans
Regulation Number864.8625
Classification Product Code
GGM  
Date Received10/03/2019
Decision Date 11/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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