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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 K142830
Device Name Ophthalmed Bending Laser Probes
Applicant
OPHTHALMED LLC
1050 Northfield Ct Ste 280
ROSWELL,  GA  30076
Applicant Contact JAY MANSOUR
Correspondent
OPHTHALMED LLC
1050 Northfield Ct Ste 280
ROSWELL,  GA  30076
Correspondent Contact JAY MANSOUR
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
HQB  
Date Received09/30/2014
Decision Date 06/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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