The following data is part of a premarket notification filed by General Medical Co. with the FDA for Drionic.
Device ID | K831320 |
510k Number | K831320 |
Device Name: | DRIONIC |
Classification | Device, Iontophoresis, Other Uses |
Applicant | GENERAL MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EGJ |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-22 |
Decision Date | 1983-07-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DRIONIC 73197831 1185615 Live/Registered |
General Medical Company 1978-12-22 |