The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Eeg Creme.
Device ID | K790818 |
510k Number | K790818 |
Device Name: | MEDI-TRACE EEG CREME |
Classification | Media, Electroconductive |
Applicant | GRAPHIC CONTROLS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GYB |
CFR Regulation Number | 882.1275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-27 |
Decision Date | 1979-06-05 |