Submission Details
| 510(k) Number | K082238 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 07, 2008 |
| Decision Date | October 01, 2008 |
| Days to Decision | 55 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
NEOMED POLYURETHANE FEEDING TUBE
Oct 2008
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K082238 is an FDA 510(k) clearance for the NEOMED POLYURETHANE FEEDING TUBE, a Tube, Feeding (Class II — Special Controls, product code FPD), submitted by Neomed, Inc. (Swanee, US). The FDA issued a Cleared decision on October 1, 2008, 55 days after receiving the submission on August 7, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
Device Classification
| Product Code | FPD — Tube, Feeding |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
Manufacturer
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