The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Transonic Hemodialysis Flow Reverser, Model B Flowrev.
| Device ID | K002816 |
| 510k Number | K002816 |
| Device Name: | TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge TRANSONIC SYSTEMS, INC. 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-11 |
| Decision Date | 2000-11-22 |