The following data is part of a premarket notification filed by Omnitech Systems, Inc. with the FDA for Omnitech Fulgurating Electrode.
| Device ID | K050454 |
| 510k Number | K050454 |
| Device Name: | OMNITECH FULGURATING ELECTRODE |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | OMNITECH SYSTEMS, INC. 456 SOUTH CAMBELL, BLDG. C Valparaiso, IN 46385 |
| Contact | Jon D Barrett |
| Correspondent | Jon D Barrett OMNITECH SYSTEMS, INC. 456 SOUTH CAMBELL, BLDG. C Valparaiso, IN 46385 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-22 |
| Decision Date | 2005-05-27 |