The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Renak-e & Renek-a Series Hollow Fiber Dialyzers.
| Device ID | K883748 |
| 510k Number | K883748 |
| Device Name: | RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | KAWASUMI LABORATORIES CO., LTD. KAWASUMI BLDG. 3-28-15 MINAMI-OHI, SHINAGAWA-KU Tokyo, JP 140 |
| Contact | Kenjiro Tani |
| Correspondent | Kenjiro Tani KAWASUMI LABORATORIES CO., LTD. KAWASUMI BLDG. 3-28-15 MINAMI-OHI, SHINAGAWA-KU Tokyo, JP 140 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-01 |
| Decision Date | 1989-01-31 |