The following data is part of a premarket notification filed by Byron Medical with the FDA for Disposable Bag Decanter.
| Device ID | K934179 |
| 510k Number | K934179 |
| Device Name: | DISPOSABLE BAG DECANTER |
| Classification | Container, I.v. |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Byron George Economidy |
| Correspondent | Byron George Economidy BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-26 |
| Decision Date | 1994-05-23 |