The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Promontory Stimulating Electrode.
| Device ID | K895081 |
| 510k Number | K895081 |
| Device Name: | PROMONTORY STIMULATING ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Carlton Cadwell |
| Correspondent | Carlton Cadwell CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-14 |
| Decision Date | 1989-11-09 |