510(k) K153095
K153095 is an FDA 510(k) premarket notification submitted by Resorbable Orthopedic Products, LLC for the device "ROP Resorbable Hemostasis Material". The FDA issued a decision of Substantially Equivalent on February 17, 2016. The device falls under product code MTJ (Wax, Bone), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2016
- Date Received
- October 26, 2015
- 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