The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Uri-cath System.
| Device ID | K852490 |
| 510k Number | K852490 |
| Device Name: | URI-CATH SYSTEM |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Contact | George E Sinko |
| Correspondent | George E Sinko GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-12 |
| Decision Date | 1985-11-05 |