FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K030593
Device Name FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC
Applicant
X-CEL CONTACTS, A WALMAN CO.
623 glacier dr.
grand junction, 
CO 
81503

Applicant Contact martin dalsing
Correspondent
X-CEL CONTACTS, A WALMAN CO.
623 glacier dr.
grand junction, 
CO 
81503

Correspodent Contact martin dalsing
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 02/25/2003
Decision Date 05/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No