The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Gambro Water Purification Unit, Models Wro 300 And Wro 300 H.
| Device ID | K093608 |
| 510k Number | K093608 |
| Device Name: | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H |
| Classification | Subsystem, Water Purification |
| Applicant | GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood, CO 80401 |
| Contact | Kae Miller |
| Correspondent | Kae Miller GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood, CO 80401 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-20 |
| Decision Date | 2010-07-29 |
| Summary: | summary |