ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)

Device, Fixation, Ac-powered, Ophthalmic

RICHMOND PRODUCTS, INC.

The following data is part of a premarket notification filed by Richmond Products, Inc. with the FDA for Animated Fixation Toys (distance And Nearpoint).

Pre-market Notification Details

Device IDK873914
510k NumberK873914
Device Name:ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)
ClassificationDevice, Fixation, Ac-powered, Ophthalmic
Applicant RICHMOND PRODUCTS, INC. 1021 SO ROGERS CIRCLE Boca Raton,  FL  33487 -2894
ContactLloyd Powell
CorrespondentLloyd Powell
RICHMOND PRODUCTS, INC. 1021 SO ROGERS CIRCLE Boca Raton,  FL  33487 -2894
Product CodeHPL  
CFR Regulation Number886.1290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-25
Decision Date1987-12-11

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