The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Pacific Hemostasis Immunodepleted Factor V Deficient Plasma (thrombosdreen Brand) (100056).
| Device ID | K972627 |
| 510k Number | K972627 |
| Device Name: | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) |
| Classification | Plasma, Coagulation Factor Deficient |
| 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 | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-14 |
| Decision Date | 1997-08-13 |
| Summary: | summary |