The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Echosight Stent Set.
| Device ID | K914280 |
| 510k Number | K914280 |
| Device Name: | ECHOSIGHT STENT SET |
| Classification | Stent, Ureteral |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-24 |
| Decision Date | 1992-01-09 |