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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 K041869
Device Name SELF RETAINING BICANALICULUS INTUBATION SET
Applicant
Fci Ophthalmics, Inc.
P.O. Box 465
76 Prospect St.
Marshfield Hills,  MA  02051
Applicant Contact LOUIS ARMAND
Correspondent
Fci Ophthalmics, Inc.
P.O. Box 465
76 Prospect St.
Marshfield Hills,  MA  02051
Correspondent Contact LOUIS ARMAND
Classification Product Code
OKS  
Date Received07/09/2004
Decision Date 11/18/2004
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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