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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Sphere
510(k) Number K992294
Device Name BIOCERAMIC ORBITAL IMPLANT
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
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received07/07/1999
Decision Date 04/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
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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