The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Gesco Aspirator.
| Device ID | K870962 |
| 510k Number | K870962 |
| Device Name: | GESCO ASPIRATOR |
| Classification | Catheters, Suction, Tracheobronchial |
| 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 | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-10 |
| Decision Date | 1987-05-22 |