The following data is part of a premarket notification filed by George King Bio-medical, Inc. with the FDA for George King Coumadin Plasma.
| Device ID | K161316 |
| 510k Number | K161316 |
| Device Name: | George King Coumadin Plasma |
| Classification | Plasma, Coagulation Control |
| Applicant | GEORGE KING BIO-MEDICAL, INC. 11771 W. 112TH ST Overland Park, KS 66210 |
| Contact | Barbara Young |
| Correspondent | Barbara Young GEORGE KING BIO-MEDICAL, INC. 11771 W. 112TH ST Overland Park, KS 66210 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-11 |
| Decision Date | 2017-02-23 |
| Summary: | summary |