The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Monopolar Emg Needle Electrode.
| Device ID | K933806 |
| 510k Number | K933806 |
| Device Name: | MONOPOLAR EMG NEEDLE ELECTRODE |
| Classification | Electrode, Needle |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Carlton M Cadwell |
| Correspondent | Carlton M Cadwell CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-04 |
| Decision Date | 1994-04-22 |