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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Punctum
510(k) Number K964774
Device Name PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
Applicant
Fci Ophthalmics, Inc.
P.O. Box 465
76 Prospect St.
Marshfield Hills,  MA  02051
Applicant Contact ANNE BOHSACK
Correspondent
Fci Ophthalmics, Inc.
P.O. Box 465
76 Prospect St.
Marshfield Hills,  MA  02051
Correspondent Contact ANNE BOHSACK
Classification Product Code
LZU  
Date Received10/22/1996
Decision Date 12/20/1996
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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