RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION

Biomicroscope, Slit-lamp, Ac-powered

RIGHTMEDICAL PRODUCTS, LLC

The following data is part of a premarket notification filed by Rightmedical Products, Llc with the FDA for Righton Zoom Slit Lamp Microscope With Photo Option.

Pre-market Notification Details

Device IDK110129
510k NumberK110129
Device Name:RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
ClassificationBiomicroscope, Slit-lamp, Ac-powered
Applicant RIGHTMEDICAL PRODUCTS, LLC 1430 BIRCHMOUNT ROAD Toronto, Ontario,  CA M1p 2e8
ContactMelanie Deslauriers
CorrespondentMelanie Deslauriers
RIGHTMEDICAL PRODUCTS, LLC 1430 BIRCHMOUNT ROAD Toronto, Ontario,  CA M1p 2e8
Product CodeHJO  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-18
Decision Date2011-08-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04562230698991 K110129 000
04562230697062 K110129 000
04562230695112 K110129 000
04562230695051 K110129 000
04562230694429 K110129 000
04562230694375 K110129 000
04580606431584 K110129 000
04580606431553 K110129 000
04580606431522 K110129 000
04562230697109 K110129 000
04562230697123 K110129 000
04562230697161 K110129 000
04562230698984 K110129 000
04562230698977 K110129 000
04562230698960 K110129 000
04562230698953 K110129 000
04562230698946 K110129 000
04562230698939 K110129 000
04562230698922 K110129 000
04562230697192 K110129 000
04580606431492 K110129 000

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