Device Classification Name |
plate, bone |
|||
---|---|---|---|---|
510(k) Number | K023810 | |||
Device Name | MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY | |||
Original Applicant |
|
|||
Original Contact | judy sokua | |||
Regulation Number | 872.4760 | |||
Classification Product Code |
|
|||
Date Received | 11/15/2002 | |||
Decision Date | 12/04/2002 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Dental |
|||
510k Review Panel |
Dental |
|||
summary |
summary |
|||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |