510(k) K984230
K984230 is an FDA 510(k) premarket notification submitted by Osteogenics Biomedical, Inc. for the device "OSTEO-MESH TM-300". The FDA issued a decision of Substantially Equivalent on February 4, 1999. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Osteogenics Biomedical, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1999
- Date Received
- November 25, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type