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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 K143086
Device Name VX120 Ophthalmic Diagnostic Device
Applicant
LUNEAU SAS
1 avenue de Malaguet
Prunay le Gillon,  FR 28360
Applicant Contact Isabelle Durand
Correspondent
LUNEAU SAS
1 avenue de Malaguet
Prunay le Gillon,  FR 28360
Correspondent Contact Isabelle Durand
Regulation Number886.1930
Classification Product Code
HKX  
Date Received10/27/2014
Decision Date 06/01/2015
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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