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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 K001227
Device Name ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT
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 Received04/17/2000
Decision Date 06/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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