510(k) K041889
K041889 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "TRI-OSTETIC". The FDA issued a decision of Substantially Equivalent on Aug 19, 2004. 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 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 2004
- Date Received
- Jul 12, 2004
- Clearance Type
- Special
- 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)