510(k) K032268
K032268 is an FDA 510(k) premarket notification submitted by Biomatlante for the device "MBCP". The FDA issued a decision of Substantially Equivalent on Dec 11, 2003. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Biomatlante has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 11, 2003
- Date Received
- Jul 23, 2003
- 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)