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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 K944910
Device Name TOMEY EM-1000 SPECULAR MICROSCOPE
Applicant
TOMEY CORPORATION USA
15825 SHADY GROVE ROAD
SUITE 30
ROCKVILLE,  MD  20850
Applicant Contact RICHARD E LIPPMAN, O.D. F.A.A.O.
Correspondent
TOMEY CORPORATION USA
15825 SHADY GROVE ROAD
SUITE 30
ROCKVILLE,  MD  20850
Correspondent Contact RICHARD E LIPPMAN, O.D. F.A.A.O.
Regulation Number886.1850
Classification Product Code
HJO  
Date Received10/05/1994
Decision Date 11/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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