The following data is part of a premarket notification filed by Kawasumi Laboratories Co., Ltd. with the FDA for Non-pvc Fluid Path Port Access Infusion Set (with And Without Injection Set).
| Device ID | K974829 |
| 510k Number | K974829 |
| Device Name: | NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | KAWASUMI LABORATORIES CO., LTD. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone KAWASUMI LABORATORIES CO., LTD. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-24 |
| Decision Date | 1998-02-12 |
| Summary: | summary |