BIOMET MICROFIXATION FACIAL PLATING SYSTEM


Device Classification Name

plate, bone

510(k) Number K121589
Device Name BIOMET MICROFIXATION FACIAL PLATING SYSTEM
Applicant
BIOMET MICROFIXATION
1520 tradeport dr.
jacksonville, 
FL 
32218

Applicant Contact lauren jasper
Correspondent
BIOMET MICROFIXATION
1520 tradeport dr.
jacksonville, 
FL 
32218

Correspodent Contact lauren jasper
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 05/31/2012
Decision Date 09/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No