The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Ad-tech's Spinal Electrode.
| Device ID | K973454 |
| 510k Number | K973454 |
| Device Name: | AD-TECH'S SPINAL ELECTRODE |
| Classification | Electrode, Depth |
| Applicant | AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Contact | Curtis Van Allen |
| Correspondent | Curtis Van Allen AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine, WI 53404 -1876 |
| Product Code | GZL |
| Subsequent Product Code | GWF |
| Subsequent Product Code | JXE |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-11 |
| Decision Date | 1998-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830032582 | K973454 | 000 |
| 00841823100771 | K973454 | 000 |
| 00841823100788 | K973454 | 000 |
| 00841823100795 | K973454 | 000 |
| 00841823100801 | K973454 | 000 |
| 00841823100818 | K973454 | 000 |
| 00841823100825 | K973454 | 000 |
| 00841823100832 | K973454 | 000 |
| 00841823100849 | K973454 | 000 |
| 00841823106407 | K973454 | 000 |
| 00841823100764 | K973454 | 000 |