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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 K133079
Device Name IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)
Applicant
Alden Optical Labs., Inc.
16576 W. 53rd Way
Golden,  CO  80403
Applicant Contact KEVIN RANDALL
Correspondent
Alden Optical Labs., Inc.
16576 W. 53rd Way
Golden,  CO  80403
Correspondent Contact KEVIN RANDALL
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/30/2013
Decision Date 12/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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