K072756 is an FDA 510(k) clearance for the NON-IV ADAPTER FOR INFANT NG TUBE, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Promedic, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on December 19, 2007, 83 days after receiving the submission on September 27, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K072756 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | September 27, 2007 |
| Decision Date | December 19, 2007 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |