ESOP CO-CR FEMORAL HEADS


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K021109
Device Name ESOP CO-CR FEMORAL HEADS
Original Applicant
FOURNITURES HOSPITALIERES
c/o pharmanet, inc.
815 connecticut ave nw ste 800
washington, 
DC 
20006

Original Contact andre weith
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 04/05/2002
Decision Date 06/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No