The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Ad-tech Subdural Electrode.
| Device ID | K970587 |
| 510k Number | K970587 |
| Device Name: | AD-TECH SUBDURAL ELECTRODE |
| Classification | Electrode, Cortical |
| Applicant | AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Contact | Curtis Van Allen Ii |
| Correspondent | Curtis Van Allen Ii AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-18 |
| Decision Date | 1997-05-09 |