The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Gesco Dual Lumen Umbilicath Ii-dl.
| Device ID | K896041 |
| 510k Number | K896041 |
| Device Name: | GESCO DUAL LUMEN UMBILICATH II-DL |
| Classification | Catheter, Umbilical Artery |
| 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 | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-17 |
| Decision Date | 1990-04-17 |