CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM


Device Classification Name

syringe, piston

510(k) Number K072330
Device Name CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
Applicant
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

Applicant Contact paula deming
Correspondent
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact paula deming
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 08/20/2007
Decision Date 12/06/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No