The following data is part of a premarket notification filed by Naimco, Inc. with the FDA for Ez-stik Electrodes.
Device ID | K050469 |
510k Number | K050469 |
Device Name: | EZ-STIK ELECTRODES |
Classification | Electrode, Cutaneous |
Applicant | NAIMCO, INC. 4120 SOUTH CREEK ROAD Chattanooga, TN 37406 |
Contact | Robert L Mcclure |
Correspondent | Robert L Mcclure NAIMCO, INC. 4120 SOUTH CREEK ROAD Chattanooga, TN 37406 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-23 |
Decision Date | 2005-05-13 |
Summary: | summary |