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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 K041598
Device Name LASEREX, MODEL LP4532
Applicant
Ellex Medical Pty. Ltd.
74 TO 86 GILBERT ST.
ADELAIDE, SOUTH AUSTRALIA,  AU 5000
Applicant Contact KEVIN HOWARD
Correspondent
Ellex Medical Pty. Ltd.
74 TO 86 GILBERT ST.
ADELAIDE, SOUTH AUSTRALIA,  AU 5000
Correspondent Contact KEVIN HOWARD
Regulation Number886.4390
Classification Product Code
HQF  
Date Received06/14/2004
Decision Date 10/06/2004
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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