The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Ibc Vrv, Model 1350.
| Device ID | K992657 |
| 510k Number | K992657 |
| Device Name: | IBC VRV, MODEL 1350 |
| Classification | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Applicant | INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744 |
| Contact | H. David Shockley, Jr. |
| Correspondent | H. David Shockley, Jr. INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744 |
| Product Code | DWD |
| CFR Regulation Number | 870.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-09 |
| Decision Date | 2000-02-18 |
| Summary: | summary |