The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Nephross I.q. Andante.
| Device ID | K874549 |
| 510k Number | K874549 |
| Device Name: | NEPHROSS I.Q. ANDANTE |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Contact | Sheldon Mazursky |
| Correspondent | Sheldon Mazursky ORGANON TEKNIKA CORP. 800 CAPITOLA DR. Durham, NC 27713 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-04 |
| Decision Date | 1988-01-29 |