The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Prisma M10 Pre Set.
| Device ID | K063183 |
| 510k Number | K063183 |
| Device Name: | PRISMA M10 PRE SET |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO RENAL PRODUCTS, INC. 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO RENAL PRODUCTS, INC. 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-19 |
| Decision Date | 2007-02-15 |
| Summary: | summary |