DEPUY 1 GENTAMICIN BONE CEMENT


Device Classification Name

bone cement

510(k) Number K023103
Device Name DEPUY 1 GENTAMICIN BONE CEMENT
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Original Contact janet g johnson
Regulation Number 888.3027
Classification Product Code
LOD  
Date Received 09/18/2002
Decision Date 09/29/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No