K903325 is an FDA 510(k) clearance for the FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on November 19, 1990, 117 days after receiving the submission on July 25, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K903325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | July 25, 1990 |
| Decision Date | November 19, 1990 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |