The following data is part of a premarket notification filed by Distronic Sterile Products, Inc. with the FDA for Core-resistant Huber Infusion Set With Y-site.
Device ID | K950597 |
510k Number | K950597 |
Device Name: | CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE |
Classification | Set, Administration, Intravascular |
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 | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-09 |
Decision Date | 1995-07-26 |