The following data is part of a premarket notification filed by Osteogenics Biomedical, Inc. with the FDA for Cytoplast Resorb, Models R-250, Rp-250, Ru-250, Rps-250, Rpl-250.
| Device ID | K993610 |
| 510k Number | K993610 |
| Device Name: | CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 |
| Classification | Bone Grafting Material, Synthetic |
| 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 | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-25 |
| Decision Date | 2000-03-02 |
| Summary: | summary |