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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 K861854
Device Name OPM SLIT LAMP MODEL P-1
Applicant
Optek Medico Co., Ltd.
Rm.#1108, Al Bergo Ochanomizu
1-19, 2 Chome, Kanda-Surugadai
Chiyoda-Ku Tokyo Japan,  JP
Applicant Contact ATSUSHI HIRAYAMA
Correspondent
Optek Medico Co., Ltd.
Rm.#1108, Al Bergo Ochanomizu
1-19, 2 Chome, Kanda-Surugadai
Chiyoda-Ku Tokyo Japan,  JP
Correspondent Contact ATSUSHI HIRAYAMA
Regulation Number886.1850
Classification Product Code
HJO  
Date Received05/14/1986
Decision Date 07/11/1986
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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