The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Gesco Catheterization Tray.
| Device ID | K882647 |
| 510k Number | K882647 |
| Device Name: | GESCO CATHETERIZATION TRAY |
| Classification | Catheter, Continuous Irrigation |
| Applicant | GESCO INTL., INC. 5714 EPSILON DR. San Antonio, TX 78249 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker GESCO INTL., INC. 5714 EPSILON DR. San Antonio, TX 78249 |
| Product Code | GBQ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-27 |
| Decision Date | 1988-09-09 |