The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Vpi Non-adhesive Condom Catheter.
| Device ID | K883119 |
| 510k Number | K883119 |
| Device Name: | VPI NON-ADHESIVE CONDOM CATHETER |
| Classification | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Contact | Sue Smith |
| Correspondent | Sue Smith COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460 |
| Product Code | EYT |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-25 |
| Decision Date | 1988-08-02 |