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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lenses, soft contact, daily wear
510(k) Number K030748
Device Name AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
Applicant
CLEARLAB PTE LTD.
2214 SANFORD DRIVE, B7
GRAND JUNCTION,  CO  81505
Applicant Contact MARTIN DALSING
Correspondent
CLEARLAB PTE LTD.
2214 SANFORD DRIVE, B7
GRAND JUNCTION,  CO  81505
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/10/2003
Decision Date 05/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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