The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Uri-cath Catheter.
| Device ID | K941672 |
| 510k Number | K941672 |
| Device Name: | URI-CATH CATHETER |
| Classification | Catheter, Urethral |
| Applicant | GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker GESCO INTL., INC. P.O. BOX 690188 San Antonio, TX 78269 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-05 |
| Decision Date | 1994-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67141980091 | K941672 | 000 |
| H67141965071 | K941672 | 000 |
| H67141900011 | K941672 | 000 |
| H67141935051 | K941672 | 000 |
| H67141935071 | K941672 | 000 |
| H67141935091 | K941672 | 000 |
| H67141950051 | K941672 | 000 |
| H67141950071 | K941672 | 000 |
| H67141950091 | K941672 | 000 |
| H67141980051 | K941672 | 000 |
| H67141980071 | K941672 | 000 |
| H67141965051 | K941672 | 000 |