SPECTACLE FRAME

Frame, Spectacle

SCIARA INTL., INC.

The following data is part of a premarket notification filed by Sciara Intl., Inc. with the FDA for Spectacle Frame.

Pre-market Notification Details

Device IDK920170
510k NumberK920170
Device Name:SPECTACLE FRAME
ClassificationFrame, Spectacle
Applicant SCIARA INTL., INC. 182-08 149TH AVE. Springfield Gardens,  NY  11413
ContactMarilyn Mahler
CorrespondentMarilyn Mahler
SCIARA INTL., INC. 182-08 149TH AVE. Springfield Gardens,  NY  11413
Product CodeHQZ  
CFR Regulation Number886.5842 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-13
Decision Date1992-03-11

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