The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Microfuse Intravenous Catheter Set.
Device ID | K840240 |
510k Number | K840240 |
Device Name: | MICROFUSE INTRAVENOUS CATHETER SET |
Classification | Catheter, Percutaneous |
Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-20 |
Decision Date | 1984-04-17 |