K091340 is an FDA 510(k) clearance for the THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350. This device is classified as a Tube, Feeding (Class II - Special Controls, product code FPD).
Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on June 9, 2009, 34 days after receiving the submission on May 6, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K091340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | May 06, 2009 |
| Decision Date | June 09, 2009 |
| Days to Decision | 34 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FPD — Tube, Feeding |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |