DESIGNS FOR VISION FIBEROPTIC LIGHT

Endoscope, Fiber Optic

DESIGNS FOR VISION, INC.

The following data is part of a premarket notification filed by Designs For Vision, Inc. with the FDA for Designs For Vision Fiberoptic Light.

Pre-market Notification Details

Device IDK032283
510k NumberK032283
Device Name:DESIGNS FOR VISION FIBEROPTIC LIGHT
ClassificationEndoscope, Fiber Optic
Applicant DESIGNS FOR VISION, INC. 49 PLAIN STREET North Attleboro,  MA  02760
ContactMary Mcnamara-cullinane
CorrespondentMary Mcnamara-cullinane
DESIGNS FOR VISION, INC. 49 PLAIN STREET North Attleboro,  MA  02760
Product CodeGDB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-24
Decision Date2003-08-20
Summary:summary

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