The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for 3 Way Silicone Foley Balloon Catheter.
| Device ID | K091767 |
| 510k Number | K091767 |
| Device Name: | 3 WAY SILICONE FOLEY BALLOON CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Contact | Brenda Davis |
| Correspondent | Brenda Davis COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-17 |
| Decision Date | 2009-10-09 |
| Summary: | summary |