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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 K902491
Device Name ECKHARDT TEMPORARY KERATOPROSTHESIS
Applicant
Dutch Ophthalmic USA, Inc.
Ten Marshall Rd.
P.O. Box 968
Kingston,  NH  03848
Applicant Contact MARK W FURLONG
Correspondent
Dutch Ophthalmic USA, Inc.
Ten Marshall Rd.
P.O. Box 968
Kingston,  NH  03848
Correspondent Contact MARK W FURLONG
Regulation Number886.3400
Classification Product Code
MLP  
Date Received06/05/1990
Decision Date 06/26/1990
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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