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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 K022413
Device Name LUNEAU 3 MIRROR LENS
Applicant
Luneau SA
Bp 252
Chartres Cedex,  FR 28005
Applicant Contact JEAN NOEL YOUNG
Correspondent
Luneau SA
Bp 252
Chartres Cedex,  FR 28005
Correspondent Contact JEAN NOEL YOUNG
Regulation Number886.1385
Classification Product Code
HJK  
Date Received07/24/2002
Decision Date 09/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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