WESTCON HORIZON 49% (HIOXIFILCON B)


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K080686
Device Name WESTCON HORIZON 49% (HIOXIFILCON B)
Applicant
WESTCON CONTACT LENS CO.
581 whiles court
erie, 
CO 
80516 -7225

Applicant Contact kevin randall
Correspondent
WESTCON CONTACT LENS CO.
581 whiles court
erie, 
CO 
80516 -7225

Correspodent Contact kevin randall
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 03/11/2008
Decision Date 04/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No