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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K843099
Device Name MAMIYA SLIT LAMP P-1
Applicant
Okada Corp.
P.O. Box 237
Tokyo, Jap, 
Applicant Contact AKIO TAKAO
Correspondent
Okada Corp.
P.O. Box 237
Tokyo, Jap, 
Correspondent Contact AKIO TAKAO
Regulation Number886.1570
Classification Product Code
HLI  
Date Received08/07/1984
Decision Date 11/21/1984
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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