The following data is part of a premarket notification filed by Tri-med Specialties, Inc. with the FDA for Tri-med Gastric Lavage System.
| Device ID | K920619 |
| 510k Number | K920619 |
| Device Name: | TRI-MED GASTRIC LAVAGE SYSTEM |
| Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Applicant | TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
| Contact | Larry Scott |
| Correspondent | Larry Scott TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
| Product Code | KDH |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-11 |
| Decision Date | 1992-09-04 |