The following data is part of a premarket notification filed by Hill-med, Inc. with the FDA for Electrosurgical Unit.
| Device ID | K981781 |
| 510k Number | K981781 |
| Device Name: | ELECTROSURGICAL UNIT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HILL-MED, INC. 7215 NW 46TH ST. Miami, FL 33166 |
| Contact | Ernesto Ackerman |
| Correspondent | Ernesto Ackerman HILL-MED, INC. 7215 NW 46TH ST. Miami, FL 33166 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-20 |
| Decision Date | 1998-12-04 |