CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K111267
Device Name CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)
Applicant
ABBCONCISE OPTICAL GROUP, LLC
806 kimball avenue
grand junction, 
CO 
81501

Applicant Contact martin dalsingh
Correspondent
ABBCONCISE OPTICAL GROUP, LLC
806 kimball avenue
grand junction, 
CO 
81501

Correspodent Contact martin dalsingh
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 05/04/2011
Decision Date 11/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No