HA ORBITAL IMPLANT


Device Classification Name

implant, eye sphere

510(k) Number K021643
Device Name HA ORBITAL IMPLANT
Original Applicant
LABORATOIRE VILLANOVA
residence blue marine
65 rue leon garet
le touquet, 

FR

f62520

Original Contact isabelle drubaix
Regulation Number 886.3320
Classification Product Code
HPZ  
Date Received 05/20/2002
Decision Date 12/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No