The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Gesco Umbili-cath.
| Device ID | K911607 |
| 510k Number | K911607 |
| Device Name: | GESCO UMBILI-CATH |
| Classification | Catheter, Umbilical Artery |
| 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 | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-10 |
| Decision Date | 1991-06-11 |