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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K950091
Device Name KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000
Applicant
Konan Medical, Inc.
10-29 Miyanishi-Cho ,
Nishinomiya
Hyogo,  JP 662-0976
Applicant Contact GEORGE MYERS
Correspondent
Konan Medical, Inc.
10-29 Miyanishi-Cho ,
Nishinomiya
Hyogo,  JP 662-0976
Correspondent Contact GEORGE MYERS
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
HRM  
Date Received01/10/1995
Decision Date 03/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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