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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 K061404
Device Name MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
Applicant
Fci Ophthalmics, Inc.
344 Annabelle Pt. Rd.
Centercille,  MA  02632
Applicant Contact HILLARD W WELCH
Correspondent
Fci Ophthalmics, Inc.
344 Annabelle Pt. Rd.
Centercille,  MA  02632
Correspondent Contact HILLARD W WELCH
Classification Product Code
OKS  
Date Received05/19/2006
Decision Date 08/07/2006
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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