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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K142398
Device Name Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
Applicant
Ellex Medical Pty. Ltd.
82 GILBERT ST.
ADELAIDE,  AU 5000
Applicant Contact KEVIN HOWARD
Correspondent
Ellex Medical Pty. Ltd.
82 GILBERT ST.
ADELAIDE,  AU 5000
Correspondent Contact KEVIN HOWARD
Regulation Number886.4390
Classification Product Code
HQF  
Date Received08/27/2014
Decision Date 07/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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