The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Drainage Depot.
| Device ID | K003078 |
| 510k Number | K003078 |
| Device Name: | MERIT DRAINAGE DEPOT |
| Classification | Bag, Bile Collecting |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | EXF |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-03 |
| Decision Date | 2000-12-11 |