The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Macro-micro Depth Electrode.
| Device ID | K041604 |
| 510k Number | K041604 |
| Device Name: | MACRO-MICRO DEPTH ELECTRODE |
| Classification | Electrode, Depth |
| 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 | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-08-16 |
| Summary: | summary |