The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Biodynamics Autotransfusion Reservoir.
| Device ID | K881631 |
| 510k Number | K881631 |
| Device Name: | BIODYNAMICS AUTOTRANSFUSION RESERVOIR |
| Classification | Apparatus, Autotransfusion |
| Applicant | BIODYNAMICS CORP. 6611 PORTWEST DR. SUITE 190 Houston, TX 77024 |
| Contact | Lucas Gordon |
| Correspondent | Lucas Gordon BIODYNAMICS CORP. 6611 PORTWEST DR. SUITE 190 Houston, TX 77024 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-14 |
| Decision Date | 1988-09-09 |