The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Prisma System R03.10a.
| Device ID | K062090 |
| 510k Number | K062090 |
| Device Name: | PRISMA SYSTEM R03.10A |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Contact | Thomas B Dowell |
| Correspondent | Thomas B Dowell GAMBRO RENAL PRODUCTS 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 | 2006-07-24 |
| Decision Date | 2006-10-18 |
| Summary: | summary |