REDDY ILLUMINATOR

Image, Illumination, Fiberoptic, For Endoscope

LUXTEC CORP.

The following data is part of a premarket notification filed by Luxtec Corp. with the FDA for Reddy Illuminator.

Pre-market Notification Details

Device IDK950960
510k NumberK950960
Device Name:REDDY ILLUMINATOR
ClassificationImage, Illumination, Fiberoptic, For Endoscope
Applicant LUXTEC CORP. 326 CLARK ST. Worcester,  MA  01606 -1214
ContactJames W Hobbs
CorrespondentJames W Hobbs
LUXTEC CORP. 326 CLARK ST. Worcester,  MA  01606 -1214
Product CodeFFS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-02
Decision Date1995-09-08

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