Gambro Healthcare · Class II · Cleared May 18, 1998
| K-number | K981085 |
| Device name | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM |
| Applicant | Gambro Healthcare |
| Product code | FIP |
| Device class | Class II |
| Decision date | May 18, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 876.5665 |
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