The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Gesco Dual Lumen Per-q-cath-dl.
| Device ID | K895942 |
| 510k Number | K895942 |
| Device Name: | GESCO DUAL LUMEN PER-Q-CATH-DL |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-11 |
| Decision Date | 1990-07-02 |