The following data is part of a premarket notification filed by Magna Advanced Technologies, Inc. with the FDA for Magnatek Electrosurgical Units Models, Esu-10, Esu-15.
| Device ID | K981416 |
| 510k Number | K981416 |
| Device Name: | MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MAGNA ADVANCED TECHNOLOGIES, INC. 7200 N.W. SEVENTH ST. 2ND FLOOR Miami, FL 33126 |
| Contact | Annie Velez |
| Correspondent | Annie Velez MAGNA ADVANCED TECHNOLOGIES, INC. 7200 N.W. SEVENTH ST. 2ND FLOOR Miami, FL 33126 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-20 |
| Decision Date | 1998-06-24 |