The following data is part of a premarket notification filed by Horizon Medical, Inc. with the FDA for Dermasense Plus Dispersive Electrode.
| Device ID | K980171 |
| 510k Number | K980171 |
| Device Name: | DERMASENSE PLUS DISPERSIVE ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HORIZON MEDICAL, INC. 1719 S. GRAND AVE. Santa Ana, CA 92705 -4808 |
| Contact | Philip L Ritger |
| Correspondent | Philip L Ritger HORIZON MEDICAL, INC. 1719 S. GRAND AVE. Santa Ana, CA 92705 -4808 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-20 |
| Decision Date | 1998-02-27 |
| Summary: | summary |