The following data is part of a premarket notification filed by Augma Biomaterials, Ltd. with the FDA for Bond Bone.
Device ID | K083858 |
510k Number | K083858 |
Device Name: | BOND BONE |
Classification | Bone Grafting Material, Synthetic |
Applicant | AUGMA BIOMATERIALS, LTD. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Contact | David J Collette |
Correspondent | David J Collette 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 | 2008-12-24 |
Decision Date | 2009-03-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17290014838014 | K083858 | 000 |
17290014838007 | K083858 | 000 |
07290014838055 | K083858 | 000 |
07290014838062 | K083858 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BOND BONE 77552842 3920202 Live/Registered |
MIS IMPLANTS TECHNOLOGIES LTD. 2008-08-21 |