EBI LACTOSORB GRAFT CONTAINMENT SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K033918
Device Name EBI LACTOSORB GRAFT CONTAINMENT SYSTEM
Applicant
EBI, L.P.
399 jefferson road
parsippany, 
NJ 
07054

Applicant Contact jon caparotta
Correspondent
EBI, L.P.
399 jefferson road
parsippany, 
NJ 
07054

Correspodent Contact jon caparotta
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 12/18/2003
Decision Date 08/16/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No