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 |