The following data is part of a premarket notification filed by Dynamic Technology Corp. with the FDA for Dynamic Hollow Fiber Dialyzer Dc-series.
| Device ID | K973291 |
| 510k Number | K973291 |
| Device Name: | DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | DYNAMIC TECHNOLOGY CORP. 6833 SAINT LAWRENCE ST. Plano, TX 75024 |
| Contact | Eric Luo |
| Correspondent | Eric Luo DYNAMIC TECHNOLOGY CORP. 6833 SAINT LAWRENCE ST. Plano, TX 75024 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1997-12-19 |
| Summary: | summary |