K990428 is an FDA 510(k) clearance for the DRAINAGE BAG. This device is classified as a Bag, Bile Collecting (Class II - Special Controls, product code EXF).
Submitted by Remington Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on August 12, 1999, 182 days after receiving the submission on February 11, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K990428 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1999 |
| Decision Date | August 12, 1999 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EXF - Bag, Bile Collecting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |