MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300

Light, Surgical, Fiberoptic

CUDA PRODUCTS CO.

The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Model M2-150/i-150/m2-150t/m3-150/m2-150,300-300.

Pre-market Notification Details

Device IDK893491
510k NumberK893491
Device Name:MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
ClassificationLight, Surgical, Fiberoptic
Applicant CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville,  FL  32217
ContactCynthia Arcusa
CorrespondentCynthia Arcusa
CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville,  FL  32217
Product CodeFST  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-04
Decision Date1989-06-22

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