The following data is part of a premarket notification filed by Omnitech Systems, Inc. with the FDA for Resectoscope Cutting Loop Electrode.
| Device ID | K964365 |
| 510k Number | K964365 |
| Device Name: | RESECTOSCOPE CUTTING LOOP ELECTRODE |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | OMNITECH SYSTEMS, INC. 456 SOUTH CAMBELL, BLDG. C Valparaiso, IN 46385 |
| Contact | Gene S Estill |
| Correspondent | Gene S Estill 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 | 1996-11-01 |
| Decision Date | 1997-04-22 |