The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Phoenix Hemodialysis Delivery System, Version 3.35.
| Device ID | K070643 |
| 510k Number | K070643 |
| Device Name: | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO, INC. 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Contact | Thomas B Dowell |
| Correspondent | Thomas B Dowell GAMBRO, INC. 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-08 |
| Decision Date | 2007-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332414042035 | K070643 | 000 |