The following data is part of a premarket notification filed by Megagen Implant Co., Ltd with the FDA for Bone Plus Bcp Eagle Eye.
| Device ID | K122240 |
| 510k Number | K122240 |
| Device Name: | BONE PLUS BCP EAGLE EYE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | MEGAGEN IMPLANT CO., LTD 325 N PUENTE ST. UNIT B Brea, CA 92821 |
| Contact | April Lee |
| Correspondent | April Lee MEGAGEN IMPLANT CO., LTD 325 N PUENTE ST. UNIT B Brea, CA 92821 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-27 |
| Decision Date | 2012-08-21 |
| Summary: | summary |