The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Autotransfusion Apparatus.
| Device ID | K873807 |
| 510k Number | K873807 |
| Device Name: | AUTOTRANSFUSION APPARATUS |
| Classification | Apparatus, Autotransfusion |
| Applicant | BIODYNAMICS CORP. 6611 PORTWEST DR. SUITE 190 Houston, TX 77024 |
| Contact | Richard L Benson |
| Correspondent | Richard L Benson 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 | 1987-09-18 |
| Decision Date | 1988-03-09 |