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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 K001089
Device Name POLYMACON
Applicant
COOPERVISION, INC.
711 NORTH RD.
SCOTTSVILLE,  NY  14546
Applicant Contact BONNIE TSYMBAL
Correspondent
COOPERVISION, INC.
711 NORTH RD.
SCOTTSVILLE,  NY  14546
Correspondent Contact BONNIE TSYMBAL
Regulation Number886.5925
Classification Product Code
LPL  
Date Received04/04/2000
Decision Date 05/19/2000
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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