510(k) K003078
K003078 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "MERIT DRAINAGE DEPOT". The FDA issued a decision of Substantially Equivalent on December 11, 2000. The device falls under product code EXF (Bag, Bile Collecting), a Class II device regulated under 21 CFR 876.5010. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2000
- Date Received
- October 3, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Bile Collecting
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type