510(k) K123243
K123243 is an FDA 510(k) premarket notification submitted by Orthocon, Inc. for the device "HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY". The FDA issued a decision of Substantially Equivalent on April 5, 2013. The device falls under product code MTJ (Wax, Bone), a Class U device. Orthocon, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2013
- Date Received
- October 17, 2012
- 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