The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Prisma M60/m100 Sets.
| Device ID | K032431 |
| 510k Number | K032431 |
| Device Name: | PRISMA M60/M100 SETS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO, INC. 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Contact | Rod J Rylands |
| Correspondent | Rod J Rylands GAMBRO, INC. 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-06 |
| Decision Date | 2003-09-15 |
| Summary: | summary |