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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K032481
FOIA Releasable 510(k) K032481
Device Name THERATEARS CONTACT LENS COMFORT DROPS
Applicant
Advanced Vision Research, Inc.
269 A Ballardvale St.
Wilmington,  MA  01887
Applicant Contact BEVERLEY D VENUTI
Correspondent
Advanced Vision Research, Inc.
269 A Ballardvale St.
Wilmington,  MA  01887
Correspondent Contact BEVERLEY D VENUTI
Regulation Number886.5928
Classification Product Code
LPN  
Subsequent Product Code
MRC  
Date Received08/12/2003
Decision Date 11/04/2003
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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