The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Dual-sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes.
Device ID | K053363 |
510k Number | K053363 |
Device Name: | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES |
Classification | Electrode, Cortical |
Applicant | AD-TECH MEDICAL INSTRUMENT CORP. 800 LEVANGER LANE Stoughton, WI 53589 |
Contact | Gary Syring |
Correspondent | Gary Syring AD-TECH MEDICAL INSTRUMENT CORP. 800 LEVANGER LANE Stoughton, WI 53589 |
Product Code | GYC |
CFR Regulation Number | 882.1310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-02 |
Decision Date | 2006-05-30 |
Summary: | summary |