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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 K140336
FOIA Releasable 510(k) K140336
Device Name OPTIMUS FUSION: SLT, YAG AND YAG/SLT
Applicant
QUANTEL MEDICAL
5 TIMBER LANE
NORTH READING,  MA  01864
Applicant Contact MAUREEN O'CONNELL
Correspondent
QUANTEL MEDICAL
5 TIMBER LANE
NORTH READING,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number886.4390
Classification Product Code
HQF  
Date Received02/10/2014
Decision Date 06/25/2014
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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