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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K954782
Device Name KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
Applicant
Kowa Optimed, Inc.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Applicant Contact SAMIA N RODRIGUEZ
Correspondent
Kowa Optimed, Inc.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact SAMIA N RODRIGUEZ
Regulation Number886.1850
Classification Product Code
HJO  
Date Received10/17/1995
Decision Date 11/24/1995
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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