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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoprosthesis, Temporary Implant, Surgical Use
510(k) Number K910828
Device Name LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS
Applicant
Ocular Instruments, Inc.
2255 116th Ave., NE
Bellevue,  WA  98004
Applicant Contact TAMSIN J ERICKSON
Correspondent
Ocular Instruments, Inc.
2255 116th Ave., NE
Bellevue,  WA  98004
Correspondent Contact TAMSIN J ERICKSON
Regulation Number886.3400
Classification Product Code
MLP  
Date Received02/27/1991
Decision Date 08/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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