The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Gambro Polyflux Hd-c4 Capillary Dialyzer/filter For Single Use.
| Device ID | K060195 |
| 510k Number | K060195 |
| Device Name: | GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Contact | Thomas B Dowell |
| Correspondent | Thomas B Dowell GAMBRO RENAL PRODUCTS 10810 WEST 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 | 2006-01-25 |
| Decision Date | 2006-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414101702 | K060195 | 000 |