The following data is part of a premarket notification filed by Omnitech Systems, Inc. with the FDA for Omnitech Resectoscope Roller Electrode.
| Device ID | K981463 |
| 510k Number | K981463 |
| Device Name: | OMNITECH RESECTOSCOPE ROLLER ELECTRODE |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| 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 | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-23 |
| Decision Date | 1998-07-17 |