The following data is part of a premarket notification filed by Omnitech Systems, Inc. with the FDA for Omnitech Hf Resection Electrodes, Omnitech Hf Vaporization Electrode.
| Device ID | K151976 |
| 510k Number | K151976 |
| Device Name: | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | OMNITECH SYSTEMS, INC. 450 SOUTH CAMPBELL ST. SUITE #2 Valparaiso, IN 46385 |
| Contact | Jon D. Barrett |
| Correspondent | Jon D. Barrett OMNITECH SYSTEMS, INC. 450 SOUTH CAMPBELL ST. SUITE #2 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 | 2015-07-16 |
| Decision Date | 2016-06-27 |