510(k) K043420
K043420 is an FDA 510(k) premarket notification submitted by Regeneration Technologies, Inc. for the device "OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE". The FDA issued a decision of Substantially Equivalent on February 10, 2005. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Regeneration Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2005
- Date Received
- December 13, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type