The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Ball Tip Fulgurating Electrode, 3 French.
| Device ID | K880748 |
| 510k Number | K880748 |
| Device Name: | BALL TIP FULGURATING ELECTRODE, 3 FRENCH |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | D Roemer |
| Correspondent | D Roemer COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-24 |
| Decision Date | 1988-08-04 |