The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Cascade Liquid Coagulation Control Levels 1, 2, And 3.
| Device ID | K992829 |
| 510k Number | K992829 |
| Device Name: | CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 |
| Classification | Plasma, Coagulation Control |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Contact | Mary D Thorsness |
| Correspondent | Mary D Thorsness MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-23 |
| Decision Date | 1999-11-22 |