510(k) K113791
K113791 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "B-GENIN, R-GENIN". The FDA issued a decision of Substantially Equivalent on March 15, 2012. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Berkeley Advanced Biomaterials, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2012
- Date Received
- December 22, 2011
- 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