The following data is part of a premarket notification filed by Distronic Sterile Products, Inc. with the FDA for Vented Solution Set.
| Device ID | K955732 |
| 510k Number | K955732 |
| Device Name: | VENTED SOLUTION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | DISTRONIC STERILE PRODUCTS, INC. 124 HERITAGE AVE. Portsmouth, NH 03801 -5645 |
| Contact | Joyce Mcdougal |
| Correspondent | Joyce Mcdougal DISTRONIC STERILE PRODUCTS, INC. 124 HERITAGE AVE. Portsmouth, NH 03801 -5645 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-19 |
| Decision Date | 1996-02-21 |