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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lacrimal stents and intubation sets
510(k) Number K113536
Device Name MASTERKA 40 MASTERKA 35 MASTERKA 30
Original Applicant
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
3308 jefferson avenue
upper level
cincinnati,  OH  45220
Original Contact barbara frant
Classification Product Code
OKS  
Date Received11/30/2011
Decision Date 08/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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