K003078 is an FDA 510(k) clearance for the MERIT DRAINAGE DEPOT. This device is classified as a Bag, Bile Collecting (Class II - Special Controls, product code EXF).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 11, 2000, 69 days after receiving the submission on October 3, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K003078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2000 |
| Decision Date | December 11, 2000 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EXF — Bag, Bile Collecting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |