The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Kawasumi Small Vein Infusion Set.
Device ID | K896896 |
510k Number | K896896 |
Device Name: | KAWASUMI SMALL VEIN INFUSION 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 |