510(k) K091636
K091636 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 June 22, 2009. 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
- June 22, 2009
- Date Received
- June 4, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wax, Bone
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type