510(k) K102071
K102071 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "OSTENE CT, AOC CT, OSTEOTENE, CERETENE". The FDA issued a decision of Substantially Equivalent on October 8, 2010. The device falls under product code MTJ (Wax, Bone), a Class U device. Ceremed , Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2010
- Date Received
- July 23, 2010
- 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