THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY


Device Classification Name

plate, bone

510(k) Number K021684
Device Name THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL 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  
Subsequent Product Code
HRS  
Date Received 05/22/2002
Decision Date 06/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No