THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY


definition

Device Classification Name

plate, bone

510(k) Number K002426
Device Name THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY
Original Applicant
BIOPLATE, INC.
6911 melrose ave.
los angeles, 
CA 
90038

Original Contact carol e jones
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 08/08/2000
Decision Date 01/26/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No