The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Kawasumi A.v. Fistula Set.
| Device ID | K873421 |
| 510k Number | K873421 |
| Device Name: | KAWASUMI A.V. FISTULA SET |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | KAWASUMI LABORATORIES CO., LTD. 21515 VANOWEN ST., NO. 101 Canoga Park, CA 91303 |
| Contact | Mark A O'brien |
| Correspondent | Mark A O'brien KAWASUMI LABORATORIES CO., LTD. 21515 VANOWEN ST., NO. 101 Canoga Park, CA 91303 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-25 |
| Decision Date | 1987-10-09 |