The following data is part of a premarket notification filed by Megagen Implant Co., Ltd with the FDA for Bone Plus Bcp.
| Device ID | K090950 |
| 510k Number | K090950 |
| Device Name: | BONE PLUS BCP |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | MEGAGEN IMPLANT CO., LTD 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Joyce Bang |
| Correspondent | Joyce Bang MEGAGEN IMPLANT CO., LTD 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-03 |
| Decision Date | 2010-07-02 |
| Summary: | summary |