The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Coagulation Control Level 2 (abnormal).
| Device ID | K984130 |
| 510k Number | K984130 |
| Device Name: | COAGULATION CONTROL LEVEL 2 (ABNORMAL) |
| Classification | Control, Plasma, Abnormal |
| Applicant | PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville, NC 28078 -8144 |
| Contact | Mark Ellis |
| Correspondent | Mark Ellis PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville, NC 28078 -8144 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-18 |
| Decision Date | 1998-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000566 | K984130 | 000 |