K072652 is an FDA 510(k) clearance for the ENTERAL FEEDING SPIKE ADAPTER, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Cedic S.R.L. (Peschiera Borromeo, IT). The FDA issued a Cleared decision on January 18, 2008, 120 days after receiving the submission on September 20, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K072652 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 20, 2007 |
| Decision Date | January 18, 2008 |
| Days to Decision | 120 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 |