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 |