The following data is part of a premarket notification filed by Hoya Corporation with the FDA for Apaceram Bone Graft Substitute.
| Device ID | K120602 |
| 510k Number | K120602 |
| Device Name: | APACERAM BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | HOYA CORPORATION 5600 WISCONSIN AVENUE #509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler HOYA CORPORATION 5600 WISCONSIN AVENUE #509 Chevy Chase, MD 20815 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-28 |
| Decision Date | 2012-03-23 |
| Summary: | summary |