The following data is part of a premarket notification filed by Gambro Healthcare with the FDA for Gambro Hemodialysis Water Treatment System.
| Device ID | K981085 |
| 510k Number | K981085 |
| Device Name: | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM |
| Classification | Subsystem, Water Purification |
| Applicant | GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Contact | William M Townsend |
| Correspondent | William M Townsend GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-25 |
| Decision Date | 1998-05-18 |