3D OCT-1 Maestro

Tomography, Optical Coherence

Topcon Corporation

The following data is part of a premarket notification filed by Topcon Corporation with the FDA for 3d Oct-1 Maestro.

Pre-market Notification Details

Device IDK161509
510k NumberK161509
Device Name:3D OCT-1 Maestro
ClassificationTomography, Optical Coherence
Applicant Topcon Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo,  JP 174-8580
ContactCharles Reisman
CorrespondentJonathan Kahan
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-01
Decision Date2016-07-28
Summary:summary

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