The following data is part of a premarket notification filed by Haidylena Medical Egypt with the FDA for Cuprophan And Hemophan Hollow Fiber Dialyzer.
| Device ID | K982337 |
| 510k Number | K982337 |
| Device Name: | CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | HAIDYLENA MEDICAL EGYPT 26, MAKRAM EBEID ST. Nasr City, Cairo, EG 11371 |
| Contact | Sameh Tamim |
| Correspondent | Sameh Tamim HAIDYLENA MEDICAL EGYPT 26, MAKRAM EBEID ST. Nasr City, Cairo, EG 11371 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-06 |
| Decision Date | 1998-12-29 |
| Summary: | summary |