The following data is part of a premarket notification filed by Dynamic Technology Corp. with the FDA for Dynamic Hollow Fiber Dialyzer Ds-series Model As-851.
| Device ID | K982134 |
| 510k Number | K982134 |
| Device Name: | DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | DYNAMIC TECHNOLOGY CORP. SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 300 |
| Contact | Yaw C Yang |
| Correspondent | Yaw C Yang DYNAMIC TECHNOLOGY CORP. SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 300 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-17 |
| Decision Date | 1999-04-14 |
| Summary: | summary |