K934348 is an FDA 510(k) clearance for the TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR. This device is classified as a Tube, Nasogastric (Class II - Special Controls, product code BSS).
Submitted by Tri-Med Specialties, Inc. (Overland Park, US). The FDA issued a Cleared decision on December 23, 1994, 472 days after receiving the submission on September 7, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K934348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1993 |
| Decision Date | December 23, 1994 |
| Days to Decision | 472 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | BSS — Tube, Nasogastric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |