The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Kawasumi Y-type Blood Administration Set.
| Device ID | K896892 |
| 510k Number | K896892 |
| Device Name: | KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | KAWASUMI LABORATORIES CO., LTD. 15902 S. WESTERN AVE. NO. 200 Gardena, CA 90247 |
| Contact | Kenjiro Tani |
| Correspondent | Kenjiro Tani KAWASUMI LABORATORIES CO., LTD. 15902 S. WESTERN AVE. NO. 200 Gardena, CA 90247 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-08 |
| Decision Date | 1990-09-12 |