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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name control, hematocrit
510(k) Number K121467
Device Name EUROTROL HEMATOCRIT CONTROL
Applicant
EUROTROL B.V.
KEPLERLAAN 20
EDE,  NL 6716 BS
Applicant Contact PAUL B.P. KOOIJMANS
Correspondent
EUROTROL B.V.
KEPLERLAAN 20
EDE,  NL 6716 BS
Correspondent Contact PAUL B.P. KOOIJMANS
Regulation Number864.8625
Classification Product Code
GLK  
Date Received05/17/2012
Decision Date 05/10/2013
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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