The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Thora-cath Trocar-type Chest Drainage Tube.
| Device ID | K851385 |
| 510k Number | K851385 |
| Device Name: | THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE |
| Classification | Catheter And Tip, Suction |
| 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 | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-09 |
| Decision Date | 1985-05-23 |