G.E.M. Water Systems · Class II · Cleared Aug 28, 1995
| K-number | K944492 |
| Device name | DIALYZER REPROCESSING SYSTEM |
| Applicant | G.E.M. Water Systems |
| Product code | LIF |
| Device class | Class II |
| Decision date | Aug 28, 1995 |
| Decision | Substantially Equivalent |
| Regulation | 876.5820 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov