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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tonometer, ac-powered
510(k) Number K162067
Device Name VX130 Ophthalmic Diagnostic Device
Applicant
LUNEAU SAS
1 AVE DE MALAGUET
PRUNAY-LE-GILLON,  FR 28360
Applicant Contact ISABELLE DURAND
Correspondent
LUNEAU SAS
1 AVE DE MALAGUET
PRUNAY-LE-GILLON,  FR 28360
Correspondent Contact ISABELLE DURAND
Regulation Number886.1930
Classification Product Code
HKX  
Subsequent Product Code
MXK  
Date Received07/26/2016
Decision Date 04/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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