KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000

Camera, Ophthalmic, Ac-powered

KONAN MEDICAL, INC.

The following data is part of a premarket notification filed by Konan Medical, Inc. with the FDA for Konan Noncon Robo Specular Microscope, Models Sp 6000 And Sp 8000.

Pre-market Notification Details

Device IDK950091
510k NumberK950091
Device Name:KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000
ClassificationCamera, Ophthalmic, Ac-powered
Applicant KONAN MEDICAL, INC. 10-29 MIYANISHI-CHO , NISHINOMIYA Hyogo,  JP 662-0976
ContactGeorge Myers
CorrespondentGeorge Myers
KONAN MEDICAL, INC. 10-29 MIYANISHI-CHO , NISHINOMIYA Hyogo,  JP 662-0976
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-10
Decision Date1995-03-01
Summary:summary

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