The following data is part of a premarket notification filed by Novosci Corp. with the FDA for Novosci Ready System, Model Rs-200.
| Device ID | K033270 |
| 510k Number | K033270 |
| Device Name: | NOVOSCI READY SYSTEM, MODEL RS-200 |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | NOVOSCI CORP. 2828 NORTH CRESCENT RIDGE DR. The Woodlands, TX 77381 -3902 |
| Contact | Leann Latham |
| Correspondent | Leann Latham NOVOSCI CORP. 2828 NORTH CRESCENT RIDGE DR. The Woodlands, TX 77381 -3902 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-10 |
| Decision Date | 2004-02-13 |
| Summary: | summary |