The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Thrombostrate Control Plasmas.
| Device ID | K000679 |
| 510k Number | K000679 |
| Device Name: | THROMBOSTRATE CONTROL PLASMAS |
| 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 | 2000-02-29 |
| Decision Date | 2000-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275000689 | K000679 | 000 |
| 00845275000610 | K000679 | 000 |
| 00845275000603 | K000679 | 000 |