FRAMES, SPECTACLE

Frame, Spectacle

RAINBOW OPTICS, INC.

The following data is part of a premarket notification filed by Rainbow Optics, Inc. with the FDA for Frames, Spectacle.

Pre-market Notification Details

Device IDK932813
510k NumberK932813
Device Name:FRAMES, SPECTACLE
ClassificationFrame, Spectacle
Applicant RAINBOW OPTICS, INC. 2 NE 40TH ST. P.O. BOX 379010 Miami,  FL  33137 -9010
ContactPerry Popkin
CorrespondentPerry Popkin
RAINBOW OPTICS, INC. 2 NE 40TH ST. P.O. BOX 379010 Miami,  FL  33137 -9010
Product CodeHQZ  
CFR Regulation Number886.5842 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-09
Decision Date1993-08-31

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