FLEXIBLE ILLUMINATOR 15

Illuminator, Non-remote

SUNCOAST MEDICAL MANUFACTURERS, INC.

The following data is part of a premarket notification filed by Suncoast Medical Manufacturers, Inc. with the FDA for Flexible Illuminator 15.

Pre-market Notification Details

Device IDK840372
510k NumberK840372
Device Name:FLEXIBLE ILLUMINATOR 15
ClassificationIlluminator, Non-remote
Applicant SUNCOAST MEDICAL MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFTF  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-27
Decision Date1984-04-24

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