ESOP HA FEMORAL STEM


Device Classification Name

prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

510(k) Number K021108
Device Name ESOP HA FEMORAL STEM
Original Applicant
FOURNITURES HOSPITALIERES
c/o pharmanet, inc.
815 connecticut ave nw ste 800
washington, 
DC 
20006

Original Contact andre weith
Regulation Number 888.3353
Classification Product Code
MEH  
Date Received 04/05/2002
Decision Date 05/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No