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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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