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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Ocular
510(k) Number K861535
Device Name OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
Applicant
CooperVision, Inc.
Coopervision Cilco
3190 160th Ave. SE
Bellevue,  WA  98008
Applicant Contact MICHAEL J ANDREWS
Correspondent
CooperVision, Inc.
Coopervision Cilco
3190 160th Ave. SE
Bellevue,  WA  98008
Correspondent Contact MICHAEL J ANDREWS
Regulation Number886.4570
Classification Product Code
HMR  
Date Received04/24/1986
Decision Date 05/14/1986
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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