510(k) K182758
K182758 is an FDA 510(k) premarket notification submitted by Mci Medical Concept Innovation, Inc. for the device "MCI - CMF System". The FDA issued a decision of Substantially Equivalent on December 5, 2019. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Mci Medical Concept Innovation, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2019
- Date Received
- September 28, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type