The following data is part of a premarket notification filed by Medicotest, Inc. with the FDA for Medicotest Electrode Paste.
Device ID | K821539 |
510k Number | K821539 |
Device Name: | MEDICOTEST ELECTRODE PASTE |
Classification | Media, Electroconductive |
Applicant | MEDICOTEST, INC. 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 | 1982-05-24 |
Decision Date | 1982-07-02 |