The following data is part of a premarket notification filed by Markwell Medical Institute, Inc. with the FDA for Button Infuser.
Device ID | K831063 |
510k Number | K831063 |
Device Name: | BUTTON INFUSER |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | MARKWELL MEDICAL INSTITUTE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-04 |
Decision Date | 1983-08-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BUTTON INFUSER 73434392 1386358 Dead/Cancelled |
MARKWELL MEDICAL INSTITUTE, INC. 1983-07-13 |