510(k) K142348
K142348 is an FDA 510(k) premarket notification submitted by Hemostasis, LLC for the device "OsteoSeal Bone Hemostat". The FDA issued a decision of Substantially Equivalent on January 23, 2015. The device falls under product code MTJ (Wax, Bone), a Class U device. Hemostasis, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2015
- Date Received
- August 22, 2014
- 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