The following data is part of a premarket notification filed by George King Bio-medical, Inc. with the FDA for Protein C Deficient Plasma.
| Device ID | K945857 |
| 510k Number | K945857 |
| Device Name: | PROTEIN C DEFICIENT PLASMA |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | George King Bio-Medical, Inc. 11771 WEST 112TH ST. Overland Park, KS 66210 |
| Contact | Judith A Gillissen |
| Correspondent | Judith A Gillissen George King Bio-Medical, Inc. 11771 WEST 112TH ST. Overland Park, KS 66210 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-10-20 |