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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 K001908
Device Name KONTUR 55 SOFT LENS
Applicant
KONTUR KONTACT LENS CO., INC.
P.O. BOX 253
LAFAYETTE,  CO  80026
Applicant Contact KEVIN M RANDALL
Correspondent
KONTUR KONTACT LENS CO., INC.
P.O. BOX 253
LAFAYETTE,  CO  80026
Correspondent Contact KEVIN M RANDALL
Regulation Number886.5925
Classification Product Code
LPL  
Date Received06/22/2000
Decision Date 08/18/2000
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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