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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, Polymethylmethacrylate, Diagnostic
510(k) Number K151961
Device Name Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
Applicant
Volk Optical, Inc.
7893 Enterprise Dr.
Mentor,  OH  44060
Applicant Contact Meghan M Leonard
Correspondent
Volk Optical, Inc.
7893 Enterprise Dr.
Mentor,  OH  44060
Correspondent Contact Meghan M Leonard
Regulation Number886.1385
Classification Product Code
HJK  
Date Received07/16/2015
Decision Date 08/18/2015
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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