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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K870265
Device Name KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
Applicant
CooperVision, Inc.
Coopervision Cilco
3190 160th Ave. SE
Bellevue,  WA  98008
Applicant Contact TOM TROTTER
Correspondent
CooperVision, Inc.
Coopervision Cilco
3190 160th Ave. SE
Bellevue,  WA  98008
Correspondent Contact TOM TROTTER
Regulation Number886.4300
Classification Product Code
KYB  
Date Received01/23/1987
Decision Date 02/20/1987
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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