The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Triple Lumen Infusioncatheters-.
Device ID | K834615 |
510k Number | K834615 |
Device Name: | TRIPLE LUMEN INFUSIONCATHETERS- |
Classification | Catheter, Infusion |
Applicant | MEDICAL COMPONENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JCY |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-04 |
Decision Date | 1984-02-14 |