OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES


Device Classification Name

lens, contact (other material) – daily

510(k) Number K081178
Device Name OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
Applicant
CONTAMAC LTD.
806 kimball avenue
grand junction, 
CO 
81501

Applicant Contact martin dalsing
Correspondent
CONTAMAC LTD.
806 kimball avenue
grand junction, 
CO 
81501

Correspodent Contact martin dalsing
Regulation Number 886.5916
Classification Product Code
HQD  
Date Received 04/25/2008
Decision Date 10/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No