The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Bio* Nephross Andante, Moderato, Allegio H.f..
| Device ID | K903567 |
| 510k Number | K903567 |
| Device Name: | BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-07 |
| Decision Date | 1990-09-24 |