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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 K070628
Device Name OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
Applicant
CONTAMAC LTD.
2214 SANFORD DRIVE,SUITE B7
GRAND JUNCTION,  CO  81505
Applicant Contact MARTIN DALSING
Correspondent
CONTAMAC LTD.
2214 SANFORD DRIVE,SUITE B7
GRAND JUNCTION,  CO  81505
Correspondent Contact MARTIN DALSING
Regulation Number886.5916
Classification Product Code
HQD  
Date Received03/07/2007
Decision Date 05/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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