The following data is part of a premarket notification filed by Osteogenics Biomedical, Inc. with the FDA for Osteo-mesh Tm-300.
| Device ID | K984230 |
| 510k Number | K984230 |
| Device Name: | OSTEO-MESH TM-300 |
| Classification | Plate, Bone |
| Applicant | OSTEOGENICS BIOMEDICAL, INC. 6401 MEADOWS WEST DR. Fort Worth, TX 76132 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer OSTEOGENICS BIOMEDICAL, INC. 6401 MEADOWS WEST DR. Fort Worth, TX 76132 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-25 |
| Decision Date | 1999-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844868041535 | K984230 | 000 |
| 00844868041528 | K984230 | 000 |