The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Ibc Vent Valve, Model 1400.
| Device ID | K992964 |
| 510k Number | K992964 |
| Device Name: | IBC VENT VALVE, MODEL 1400 |
| Classification | Valve, Pressure Relief, Cardiopulmonary Bypass |
| Applicant | INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744 |
| Contact | H. David Shocklet, Jr |
| Correspondent | H. David Shocklet, Jr INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin, TX 78744 |
| Product Code | MNJ |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-02 |
| Decision Date | 1999-11-19 |
| Summary: | summary |