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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical
510(k) Number K881095
Device Name KOI(TM) INSTRUMENT TRAYS
Applicant
CooperVision, Inc.
Coopervision Cilco
3190 160th Ave. SE
Bellevue,  WA  98008
Applicant Contact THERESA N CORLETT
Correspondent
CooperVision, Inc.
Coopervision Cilco
3190 160th Ave. SE
Bellevue,  WA  98008
Correspondent Contact THERESA N CORLETT
Regulation Number878.4800
Classification Product Code
LRP  
Date Received03/15/1988
Decision Date 04/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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