K921104 is an FDA 510(k) clearance for the LOPEZ VALVE WITH NG SUMP TUBE. This device is classified as a Tube, Double Lumen For Intestinal Decompression And/or Intubation (Class II - Special Controls, product code FEG).
Submitted by Icu Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on October 26, 1992, 231 days after receiving the submission on March 9, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K921104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1992 |
| Decision Date | October 26, 1992 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FEG — Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |