The following data is part of a premarket notification filed by Nikkiso Co. Ltd. with the FDA for Nikkiso Nd-14 Parallel Flow Dialyzer.
| Device ID | K803068 |
| 510k Number | K803068 |
| Device Name: | NIKKISO ND-14 PARALLEL FLOW DIALYZER |
| Classification | Dialyzer, Parallel Flow |
| Applicant | NIKKISO CO. LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-04 |
| Decision Date | 1981-03-04 |