The following data is part of a premarket notification filed by Apheresis Technologies, Inc. with the FDA for Plasma Discard Bags.
| Device ID | K926409 |
| 510k Number | K926409 |
| Device Name: | PLASMA DISCARD BAGS |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | APHERESIS TECHNOLOGIES, INC. P.O. BOX 2081 PALM HARBOR, FL 34682 |
| Contact | PATRICK J LAMB |
| Correspondent | PATRICK J LAMB APHERESIS TECHNOLOGIES, INC. P.O. BOX 2081 PALM HARBOR, FL 34682 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-21 |
| Decision Date | 1993-03-02 |