KOWA SC-1200 PHOTO SLIT LAMP SYSTEM

Camera, Ophthalmic, Ac-powered

KOWA OPTIMED, INC.

The following data is part of a premarket notification filed by Kowa Optimed, Inc. with the FDA for Kowa Sc-1200 Photo Slit Lamp System.

Pre-market Notification Details

Device IDK955442
510k NumberK955442
Device Name:KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
ClassificationCamera, Ophthalmic, Ac-powered
Applicant KOWA OPTIMED, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington,  DC  20005
ContactSamia N Rodriguez
CorrespondentSamia N Rodriguez
KOWA OPTIMED, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington,  DC  20005
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-28
Decision Date1996-01-03

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