The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Umbili-cath-s-dl.
| Device ID | K940952 |
| 510k Number | K940952 |
| Device Name: | UMBILI-CATH-S-DL |
| Classification | Catheter, Umbilical Artery |
| 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 | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-01 |
| Decision Date | 1994-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67143850051 | K940952 | 000 |
| H67142850051 | K940952 | 000 |
| H67142835051 | K940952 | 000 |
| H67142828051 | K940952 | 000 |
| H67142750051 | K940952 | 000 |
| H67142735051 | K940952 | 000 |