The following data is part of a premarket notification filed by Dynamic Technology Corp. with the FDA for Dynamic Hollow Fiber Dialyzer Dh-series, Model Ah 90111.
| Device ID | K990159 |
| 510k Number | K990159 |
| Device Name: | DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| 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 | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-04-19 |
| Summary: | summary |