The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Urological Wire Guide W/hydromer Coating.
| Device ID | K880100 |
| 510k Number | K880100 |
| Device Name: | COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING |
| Classification | Catheter, Urological |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Frederick D Roemer |
| Correspondent | Frederick D Roemer COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-12 |
| Decision Date | 1988-03-15 |