SLIT LAMP SL-D701

Biomicroscope, Slit-lamp, Ac-powered

TOPCON CORP.

The following data is part of a premarket notification filed by Topcon Corp. with the FDA for Slit Lamp Sl-d701.

Pre-market Notification Details

Device IDK133667
510k NumberK133667
Device Name:SLIT LAMP SL-D701
ClassificationBiomicroscope, Slit-lamp, Ac-powered
Applicant TOPCON CORP. 5 TIMBER LANE North Reading,  MA  01864
ContactMaureen O'connell
CorrespondentMaureen O'connell
TOPCON CORP. 5 TIMBER LANE North Reading,  MA  01864
Product CodeHJO  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-29
Decision Date2014-08-26
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.