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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Ave.
Grand Junction,  CO  81501
Applicant Contact MARTIN DALSING
Correspondent
Contamac, Ltd.
806 Kimball Ave.
Grand Junction,  CO  81501
Correspondent Contact MARTIN DALSING
Regulation Number886.5916
Classification Product Code
HQD  
Date Received04/25/2008
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
Predetermined Change
Control Plan Authorized		 No
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