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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plasma, coagulation control
510(k) Number K161316
Device Name George King Coumadin Plasma
Applicant
GEORGE KING BIO-MEDICAL, INC.
11771 w. 112th st
overland park,  KS  66210
Applicant Contact barbara young
Correspondent
GEORGE KING BIO-MEDICAL, INC.
11771 w. 112th st
overland park,  KS  66210
Correspondent Contact barbara young
Regulation Number864.5425
Classification Product Code
GGN  
Date Received05/11/2016
Decision Date 02/23/2017
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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