510(k) K180853
K180853 is an FDA 510(k) premarket notification submitted by Elute, Inc. for the device "EP Granules BVF". The FDA issued a decision of Substantially Equivalent on Aug 6, 2018. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Elute, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 6, 2018
- Date Received
- Apr 2, 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