The following data is part of a premarket notification filed by Staodynamics, Inc. with the FDA for Electrodes, Staoderm Sterile.
Device ID | K790542 |
510k Number | K790542 |
Device Name: | ELECTRODES, STAODERM STERILE |
Classification | Electrode, Cutaneous |
Applicant | STAODYNAMICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-03-22 |
Decision Date | 1979-05-23 |