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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 K123831
Device Name OPHTACATH KIT
Applicant
France Chirurgae Instrumentation
3308 Jefferson Ave., Upper Level
Cincinnati,  OH  45220
Applicant Contact BARBARA S FANT
Correspondent
France Chirurgae Instrumentation
3308 Jefferson Ave., Upper Level
Cincinnati,  OH  45220
Correspondent Contact BARBARA S FANT
Classification Product Code
OKS  
Date Received12/12/2012
Decision Date 07/29/2013
Decision Substantially Equivalent (SESE)
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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