The following data is part of a premarket notification filed by M.i.s. Implants Technologies Ltd. with the FDA for Bond Bone.
Device ID | K101014 |
510k Number | K101014 |
Device Name: | BOND BONE |
Classification | Bone Grafting Material, Synthetic |
Applicant | M.I.S. IMPLANTS TECHNOLOGIES LTD. P.O. BOX 7 Bar Lev Industrial Park, IL 20156 |
Contact | Iman Khorshid |
Correspondent | Iman Khorshid M.I.S. IMPLANTS TECHNOLOGIES LTD. P.O. BOX 7 Bar Lev Industrial Park, IL 20156 |
Product Code | LYC |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-04-12 |
Decision Date | 2010-10-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290108990089 | K101014 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BOND BONE 77552842 3920202 Live/Registered |
MIS IMPLANTS TECHNOLOGIES LTD. 2008-08-21 |