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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 K123431
Device Name DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D
Applicant
Dreamcon Co., Ltd.
27001 La Paz Rd.
Suite 312
Mission Viejo,  CA  92691
Applicant Contact ALBERT REGO
Correspondent
Dreamcon Co., Ltd.
27001 La Paz Rd.
Suite 312
Mission Viejo,  CA  92691
Correspondent Contact ALBERT REGO
Regulation Number886.5925
Classification Product Code
LPL  
Date Received11/07/2012
Decision Date 06/17/2013
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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