The following data is part of a premarket notification filed by Tri-med Specialties, Inc. with the FDA for Tri-med Quick-step Gastric Lavage Tube Sizes 18fr, 22fr, 32fr.
| Device ID | K934348 |
| 510k Number | K934348 |
| Device Name: | TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR |
| Classification | Tube, Nasogastric |
| 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 | BSS |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-07 |
| Decision Date | 1994-12-23 |