MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM


codes

Device Classification Name

plate, bone

510(k) Number K002879
Device Name MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
Original Applicant
BIOPLATE, INC.
6911 melrose ave.
los angeles, 
CA 
90038

Original Contact eric v hohenstein
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 09/15/2000
Decision Date 10/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Special
Reviewed by Third Party No

Combination Product

No