The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Neomed Non Gel-r Total Adhesive Conduct. Electrode.
| Device ID | K863360 |
| 510k Number | K863360 |
| Device Name: | NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-02 |
| Decision Date | 1986-09-12 |