The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Port Access Infusion Set.
| Device ID | K921901 |
| 510k Number | K921901 |
| Device Name: | PORT ACCESS INFUSION SET |
| Classification | Pump, Infusion |
| Applicant | KAWASUMI LABORATORIES CO., LTD. KAWASUMI BLDG. 3-28-15 MINAMI-OHI, SHINAGAWA-KU Tokyo, JP 140 |
| Contact | Shozo Moriyama |
| Correspondent | Shozo Moriyama KAWASUMI LABORATORIES CO., LTD. KAWASUMI BLDG. 3-28-15 MINAMI-OHI, SHINAGAWA-KU Tokyo, JP 140 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-22 |
| Decision Date | 1993-09-10 |