SPECTACLE FRAME - DANIELLE

Frame, Spectacle

ROSEBURG SA

The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Spectacle Frame - Danielle.

Pre-market Notification Details

Device IDK871688
510k NumberK871688
Device Name:SPECTACLE FRAME - DANIELLE
ClassificationFrame, Spectacle
Applicant ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington,  DC  20007
ContactDarienne Moyer
CorrespondentDarienne Moyer
ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington,  DC  20007
Product CodeHQZ  
CFR Regulation Number886.5842 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-29
Decision Date1987-05-29

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