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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 K081565
Device Name INTEGRE PRO, MODEL L2RY
Applicant
Ellex Medical Pty, Ltd.
82 Gilbert St.
Adelaide, South Australia,  AU 5000
Applicant Contact KEVIN HOWARD
Correspondent
Ellex Medical Pty, Ltd.
82 Gilbert St.
Adelaide, South Australia,  AU 5000
Correspondent Contact KEVIN HOWARD
Regulation Number886.4390
Classification Product Code
HQF  
Date Received06/04/2008
Decision Date 07/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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