The following data is part of a premarket notification filed by Gambro Healthcare with the FDA for Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/filters.
| Device ID | K982413 |
| 510k Number | K982413 |
| Device Name: | COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1999-04-21 |
| Summary: | summary |