The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Non/gel Fully Adhesive Dispersive Electrode 3428,.
| Device ID | K851305 |
| 510k Number | K851305 |
| Device Name: | NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428, |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Jim Lenick |
| Correspondent | Jim Lenick 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 | 1985-04-01 |
| Decision Date | 1985-09-06 |