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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 K943125
Device Name QUADRASPHERIC FUNDUS LENS
Applicant
Volk Optical, Inc.
Bond Ct. Bldg.
1300 E. Ninth St., Suite 900
Cleveland,  OH  44114
Applicant Contact JAMES A GOLDSMITH
Correspondent
Volk Optical, Inc.
Bond Ct. Bldg.
1300 E. Ninth St., Suite 900
Cleveland,  OH  44114
Correspondent Contact JAMES A GOLDSMITH
Regulation Number886.1385
Classification Product Code
HJK  
Date Received06/29/1994
Decision Date 09/02/1994
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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