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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 K121324
Device Name AVT NATURASOFT
Applicant
ADVANCED VISION TECHNOLOGIES
806 KIMBALL AVE
GRAND JUNCTION,  CO  81501
Applicant Contact MARTIN DALSING
Correspondent
ADVANCED VISION TECHNOLOGIES
806 KIMBALL AVE
GRAND JUNCTION,  CO  81501
Correspondent Contact MARTIN DALSING
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/02/2012
Decision Date 08/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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