510(k) K180121
K180121 is an FDA 510(k) premarket notification submitted by Cellumed Co., Ltd. for the device "Rafugen DBM". The FDA issued a decision of Substantially Equivalent on Apr 11, 2018. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 11, 2018
- Date Received
- Jan 16, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type
- 510(k)