510(k) K142157
K142157 is an FDA 510(k) premarket notification submitted by Heraeus Medical GmbH for the device "PALACOS R+G PRO". The FDA issued a decision of Substantially Equivalent on September 5, 2014. The device falls under product code LOD (Bone Cement), a Class II device regulated under 21 CFR 888.3027. Heraeus Medical GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2014
- Date Received
- August 6, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Cement
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type