MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM


Device Classification Name

plate, bone

510(k) Number K011380
Device Name MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
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 05/07/2001
Decision Date 05/14/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Special
Reviewed by Third Party No

Combination Product

No