The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Coagulation Control Plasma(abnormal)level 0.
| Device ID | K971428 |
| 510k Number | K971428 |
| Device Name: | COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 |
| Classification | Plasma, Coagulation Control |
| Applicant | PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville, NC 28078 -8144 |
| Contact | Laura A Worfolk |
| Correspondent | Laura A Worfolk PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville, NC 28078 -8144 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-17 |
| Decision Date | 1997-06-17 |
| Summary: | summary |