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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 K010256
Device Name ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL
Applicant
OPTI-CENTRE LABORATORIES
623 GLACIER DR.
GRAND JUNCTION,  CO  81503
Applicant Contact MARTIN DALSING
Correspondent
OPTI-CENTRE LABORATORIES
623 GLACIER DR.
GRAND JUNCTION,  CO  81503
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received01/29/2001
Decision Date 03/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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