The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Gambro Prismaflex And Gambro Prismaflex M60 & M100 Sets.
| Device ID | K041005 |
| 510k Number | K041005 |
| Device Name: | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-19 |
| Decision Date | 2004-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414064557 | K041005 | 000 |
| 37332414064540 | K041005 | 000 |