The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Infumix Mixing Container.
| Device ID | K870052 |
| 510k Number | K870052 |
| Device Name: | INFUMIX MIXING CONTAINER |
| Classification | Container, I.v. |
| Applicant | BIODYNAMICS CORP. 6611 PORTWEST DR. SUITE 190 Houston, TX 77024 |
| Contact | Guest, M.d. |
| Correspondent | Guest, M.d. BIODYNAMICS CORP. 6611 PORTWEST DR. SUITE 190 Houston, TX 77024 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-07 |
| Decision Date | 1987-02-27 |