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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
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