The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Ibc Cardiac Suction Ward.
| Device ID | K963756 |
| 510k Number | K963756 |
| Device Name: | IBC CARDIAC SUCTION WARD |
| Classification | Sucker, Cardiotomy Return, 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 | DTS |
| CFR Regulation Number | 870.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-17 |
| Decision Date | 1997-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814321020421 | K963756 | 000 |
| 00814321020384 | K963756 | 000 |
| 10814321020411 | K963756 | 000 |
| 10814321020374 | K963756 | 000 |