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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 K010454
Device Name THE ALBERTA LENS SM2, SULFOCON B
Applicant
Progressive Optical Research , Ltd.
#20, 1410-40th Ave., NE
Calgary, Alberta,  CA T2E 6L1
Applicant Contact NICK NOVICKY
Correspondent
Progressive Optical Research , Ltd.
#20, 1410-40th Ave., NE
Calgary, Alberta,  CA T2E 6L1
Correspondent Contact NICK NOVICKY
Regulation Number886.5916
Classification Product Code
HQD  
Date Received02/15/2001
Decision Date 08/01/2001
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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