The following data is part of a premarket notification filed by Vital Scientific N.v. with the FDA for Fibron-1, Fibron-4, Quikcoag, Fibron.
| Device ID | K021976 |
| 510k Number | K021976 |
| Device Name: | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON |
| Classification | Instrument, Coagulation |
| 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 | KQG |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-17 |
| Decision Date | 2002-10-25 |
| Summary: | summary |