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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 K141699
Device Name VASSEN COLOR
Applicant
Vassen Co., Ltd.
474 NE 61st Pl.
Hillsboro,  OR  97124
Applicant Contact BRET ANDRE
Correspondent
Vassen Co., Ltd.
474 NE 61st Pl.
Hillsboro,  OR  97124
Correspondent Contact BRET ANDRE
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received06/24/2014
Decision Date 10/07/2014
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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