510(k) K023703
K023703 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "BI-OSTETIC". The FDA issued a decision of Substantially Equivalent on Jan 30, 2003. 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
- Jan 30, 2003
- Date Received
- Nov 4, 2002
- 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)