The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Wro 300 Water Purification System For Hemodialysis.
| Device ID | K042797 |
| 510k Number | K042797 |
| Device Name: | WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Contact | Rod J Rylands |
| Correspondent | Rod J Rylands GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-08 |
| Decision Date | 2005-03-09 |
| Summary: | summary |