The following data is part of a premarket notification filed by Vital Scientific N.v. with the FDA for Vital Scientific Coagulation Control,coagulation Control Level 1,2,3,quikcoag Coagulation Control.
| Device ID | K022046 |
| 510k Number | K022046 |
| Device Name: | VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL |
| Classification | Plasma, Coagulation Control |
| Applicant | VITAL SCIENTIFIC N.V. ONE GATEWAY CENTER SUITE 411 Newton, MA 02458 |
| Contact | Israel M Stein |
| Correspondent | Israel M Stein VITAL SCIENTIFIC N.V. ONE GATEWAY CENTER SUITE 411 Newton, MA 02458 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-24 |
| Decision Date | 2002-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10627944000087 | K022046 | 000 |
| 10627944000070 | K022046 | 000 |
| 10627944000063 | K022046 | 000 |
| 00850053916229 | K022046 | 000 |
| 00850053916212 | K022046 | 000 |