The following data is part of a premarket notification filed by Distronic Sterile Products, Inc. with the FDA for Intravascular Administration Set.
| Device ID | K945184 |
| 510k Number | K945184 |
| Device Name: | INTRAVASCULAR ADMINISTRATION SET |
| Classification | Tubing, Fluid Delivery |
| Applicant | DISTRONIC STERILE PRODUCTS, INC. 124 HERITAGE AVE. Portsmouth, NH 03801 -5645 |
| Contact | Joyce Mcdougall |
| Correspondent | Joyce Mcdougall DISTRONIC STERILE PRODUCTS, INC. 124 HERITAGE AVE. Portsmouth, NH 03801 -5645 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-24 |
| Decision Date | 1995-02-08 |