The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Spectrum Silicone Foley Catheter.
| Device ID | K000251 |
| 510k Number | K000251 |
| Device Name: | SPECTRUM SILICONE FOLEY CATHETER |
| Classification | Catheter, Urological (antimicrobial) And Accessories |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Brenda Davis |
| Correspondent | Brenda Davis COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | MJC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-27 |
| Decision Date | 2000-08-30 |