The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Laser Fiber Delivery/cleaning Catheter.
| Device ID | K960768 |
| 510k Number | K960768 |
| Device Name: | LASER FIBER DELIVERY/CLEANING CATHETER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Rick Lynkins |
| Correspondent | Rick Lynkins COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-26 |
| Decision Date | 1996-05-14 |
| Summary: | summary |