510(k) K013764
K013764 is an FDA 510(k) premarket notification submitted by Osteogenics Biomedical, Inc. for the device "IMMIX BONE GRAFT EXTENDER". The FDA issued a decision of Substantially Equivalent on May 16, 2002. The device falls under product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction), a Class II device regulated under 21 CFR 878.3500. Osteogenics Biomedical, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2002
- Date Received
- November 13, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- Device Class
- Class II
- Regulation Number
- 878.3500
- Review Panel
- SU
- Submission Type