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U.S. Department of Health and Human Services

Devices@FDA
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Help | Download Files | More about CDRH 510(K)

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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K081865
Device Name PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
Applicant
CooperVision, Inc.
711 N. Rd.
Scottsville,,  NY  14546
Applicant Contact BONNIE TSYMBAL
Correspondent
CooperVision, Inc.
711 N. Rd.
Scottsville,,  NY  14546
Correspondent Contact BONNIE TSYMBAL
Regulation Number886.5925
Classification Product Code
LPL  
Date Received07/01/2008
Decision Date 09/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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