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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 K133019
Device Name FIBERION OPHTHALMIC ENDOLASER PROBE
Applicant
Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim
Bebek Yolu Sokagi 23/3 Etiler
Istanbul,  TR 34337
Applicant Contact MEHMET MELEK
Correspondent
Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim
Bebek Yolu Sokagi 23/3 Etiler
Istanbul,  TR 34337
Correspondent Contact MEHMET MELEK
Regulation Number886.4390
Classification Product Code
HQF  
Date Received09/26/2013
Decision Date 02/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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