The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Cueva Cranial Nerve Electrode.
| Device ID | K944061 |
| 510k Number | K944061 |
| Device Name: | CUEVA CRANIAL NERVE ELECTRODE |
| Classification | Electrode, Depth |
| Applicant | AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Contact | David A Putz |
| Correspondent | David A Putz AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-19 |
| Decision Date | 1995-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 90841823100866 | K944061 | 000 |
| 90841823100859 | K944061 | 000 |