The following data is part of a premarket notification filed by Edwards Lifesciences Services Gmbh with the FDA for Edwards Aquarius System, Model Ge-f098-00.
| Device ID | K090682 |
| 510k Number | K090682 |
| Device Name: | EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | EDWARDS LIFESCIENCES SERVICES GMBH BIOPARK BROADWATER ROAD Welwyn Garden City, GB Al7 3ax |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong EDWARDS LIFESCIENCES SERVICES GMBH BIOPARK BROADWATER ROAD Welwyn Garden City, GB Al7 3ax |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-16 |
| Decision Date | 2009-11-19 |
| Summary: | summary |