The following data is part of a premarket notification filed by Augma Biomaterials, Ltd. with the FDA for Bond Apatite.
Device ID | K121177 |
510k Number | K121177 |
Device Name: | BOND APATITE |
Classification | Bone Grafting Material, Synthetic |
Applicant | AUGMA BIOMATERIALS, LTD. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Contact | Kevin A Thomas |
Correspondent | Kevin A Thomas AUGMA BIOMATERIALS, LTD. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-18 |
Decision Date | 2013-12-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290108992533 | K121177 | 000 |
07290108992526 | K121177 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BOND APATITE 85450734 4495220 Live/Registered |
Augma Biomaterials 2011-10-19 |