510(k) K060987
K060987 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31". The FDA issued a decision of Substantially Equivalent on November 2, 2006. The device falls under product code MTJ (Wax, Bone), a Class U device. Cp Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2006
- Date Received
- April 10, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wax, Bone
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type