The following data is part of a premarket notification filed by Scientific Medical Devices, Inc. with the FDA for Smd Electrodes.
| Device ID | K943009 |
| 510k Number | K943009 |
| Device Name: | SMD ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | SCIENTIFIC MEDICAL DEVICES, INC. 562 LAKELAND PLAZA SUITE 256 Cumming, GA 30130 |
| Contact | Kent H Kohnken |
| Correspondent | Kent H Kohnken SCIENTIFIC MEDICAL DEVICES, INC. 562 LAKELAND PLAZA SUITE 256 Cumming, GA 30130 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-24 |
| Decision Date | 1995-02-21 |