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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 K003079
Device Name SPECIALTY TINT SOFT CONTACT LENS
Applicant
Specialty Tint
1325 Progress Dr.
Front Royal,  VA  22630
Applicant Contact ROBERT BREECE
Correspondent
Specialty Tint
1325 Progress Dr.
Front Royal,  VA  22630
Correspondent Contact ROBERT BREECE
Regulation Number886.5925
Classification Product Code
LPL  
Date Received10/03/2000
Decision Date 11/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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