Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-