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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoprosthesis, Permanent Implant
510(k) Number K915062
Device Name DOHLMAN DOANE KERATOPROTHESIS
Applicant
Mackeen Consultants, Ltd.
4903 Sangamore Rd.
Bethesda,  MD  20816
Applicant Contact DONALD L.MACKEEN
Correspondent
Mackeen Consultants, Ltd.
4903 Sangamore Rd.
Bethesda,  MD  20816
Correspondent Contact DONALD L.MACKEEN
Regulation Number886.3400
Classification Product Code
HQM  
Date Received11/08/1991
Decision Date 01/21/1992
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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