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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biomicroscope, slit-lamp, ac-powered
510(k) Number K063352
Device Name ELLEX SLIT LAMP, MODEL 30XL
Applicant
TAKAGI SEIKO CO., LTD.
82 GILBERT STREET
ADELAIDE, SOUTH AUSTRALIA,  AU 5000
Applicant Contact KEVIN HOWARD
Correspondent
TAKAGI SEIKO CO., LTD.
82 GILBERT STREET
ADELAIDE, SOUTH AUSTRALIA,  AU 5000
Correspondent Contact KEVIN HOWARD
Regulation Number886.1850
Classification Product Code
HJO  
Date Received11/06/2006
Decision Date 03/13/2007
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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