R.L. MEDICAL TWIN LIGHT SOURCE

Light Source, Fiberoptic, Routine

TRIDAK DIVISION OF INDICON, INC.

The following data is part of a premarket notification filed by Tridak Division Of Indicon, Inc. with the FDA for R.l. Medical Twin Light Source.

Pre-market Notification Details

Device IDK842609
510k NumberK842609
Device Name:R.L. MEDICAL TWIN LIGHT SOURCE
ClassificationLight Source, Fiberoptic, Routine
Applicant TRIDAK DIVISION OF INDICON, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-05
Decision Date1984-08-09

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